Antirefluxchirurgie - Technieken

Beoordeeld: 14-10-2024

Uitgangsvraag

Wat is de fundoplicatie van voorkeur bij volwassenen met gastro-oesofageale refluxziekte?

Op basis van welke criteria zou een andere fundoplicatie de voorkeur hebben?

Aanbeveling

Beslis samen met de patiënt over de optimale fundoplicatie voor gastro-oesofageale refluxziekte. Bespreek hierbij de voor- en nadelen van partiële fundoplicatie (180 graden anterieur fundoplicatie (LAF) en 270 graden posterieur fundoplicatie volgens Toupet (LTF)) in vergelijking met een 360 graden fundoplicatie volgens Nissen (LNF).

De keuze wordt mede bepaald door de wensen en verwachtingen van de patiënt.

Geef hierbij aan dat:

Iedere fundoplicatie (LAF, LTF en LNF) leidt tot een zeer hoge kans op algemene tevredenheid (70-98% na 10 jaar);
Een partiële fundoplicatie (LAF of LTF) heeft minder bijwerkingen (opgeblazen gevoel, dysfagie, flatulentie);
LNF geeft op lange termijn enigszins betere refluxcontrole t.o.v. LAF of LTF, wat vervolgens leidt tot minder PPI gebruik, en betere lange termijn tevredenheidsscore.

Overwegingen

Voor- en nadelen van de interventie en de kwaliteit van het bewijs

Op basis van de geïncludeerde studies zijn we onzeker over het effect van partiële fundoplicaties (180 graden anterieur verder aangeduid als LAF en 270 graden posterieur volgens Toupet verder aangeduid als LTF) in vergelijking met een 360 graden fundoplicatie volgens Nissen (verder aangeduide als LNF) op de cruciale uitkomstmaat kwaliteit van leven na zes tot 18 maanden, vijf jaar en tien jaar follow-up. Dit geldt specifiek voor de kwaliteit van leven (ernst van symptomen na de operatie, gemeten met de Visick score). De bewijskracht van de gevonden resultaten is erg beperkt vanwege met name het risico op imprecisie (kleine populaties en loss-to-follow-up) en inconsistentie van de resultaten.

Ook zijn we onzeker over het effect van de LAF op de belangrijke uitkomstmaten dysfagie (na zes tot 18 maanden en na tien jaar follow-up), refluxcontrole (na zes tot 18 maanden en na vijf jaar follow-up), opgeblazen gevoel (na zes tot 18 maanden en na 10 jaar follow-up), het gebruik van protonpompremmers (PPI, na vijf jaar en na 10 jaar follow-up). De studies suggereren dat een LAF mogelijk een positief effect kunnen hebben op winderigheid na zes tot 18 maanden en na vijf jaar follow-up in vergelijking met LNF.

Voor een LTF zijn we onzeker over het effect op dysfagie (na zes tot 18 maanden en na tien jaar follow-up), refluxcontrole (12 maanden en vijf jaar follow-up), het gebruik van PPI’s (na zes tot 18 maanden en na vijf jaar follow-up) in vergelijking met LNF. Voor opgeblazen gevoel en winderigheid zijn geen uitkomsten gevonden.

De overkoepelende bewijskracht voor deze module is zeer laag. Bovendien ontbreekt informatie over sommige bijwerkingen, zoals winderigheid en opgeblazen gevoel. Er is duidelijk sprake van een kennislacune.

Waarden en voorkeuren van patiënten (en evt. hun verzorgers)

Uitgaande van de Visick score welke onderscheid maakt in de mate van aanwezigheid van symptomen lijkt de voorkeur van de patiënt mogelijk uit te gaan naar een LNF (360-graden fundoplicatie) vanwege een groter fractie van patiënten met lagere Visick score na LNF in vergelijking met LAF. De Visick score is echter gericht op de hoofdklacht (reflux/zuurbranden) en houdt minder rekening met bijwerkingen, welke frequenter op lijken te treden na LNF. De algemene tevredenheid (Visick score) na een fundoplicatie is hoog (70-98%, Tabel 1 en 5). In de keuze voor een fundoplicatie is de hoofdklacht/ behandelwens relevant. Als de behandelwens stoppen van PPI is, kan wellicht beter gekozen worden voor een LNF (mits er geen sprake is van ineffectieve slokdarmmotiliteit). Als hinder van bijwerkingen als opgeblazen gevoel (bloating) en winderigheid een belangrijke rol spelen is een partiële fundoplicatie (LAF of LTF) een betere optie.

Kosten (middelenbeslag)

Overwegingen omtrent kosten spelen geen rol bij de huidige aanbeveling.

Aanvaardbaarheid, haalbaarheid en implementatie

Het implementeren van een LTF of een LAF als fundoplicatie van voorkeur bij patiënten met gastro-oesofageale refluxziekte (GORZ) in Nederland zou eenvoudig zijn aangezien de meeste chirurgen de LAF of LTF al als standaard hanteren. Technisch zijn een LNF, LTF of LAF van een gelijk niveau d.w.z. iedere chirurg met ervaring in de antirefluxchirurgie kan een partiële fundoplicatie (LAF of LTF) en een totale fundoplicatie (LNF) verrichten. Er is in deze module geen vergelijking gemaakt tussen LAF en LTF, maar deze lijken gelijke resultaten te geven.

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

Op de vraag welke fundoplicatie de voorkeur zou moeten krijgen bij patiënten met GORZ is geen eenduidig antwoord te geven. Op basis van de geanalyseerde literatuur zijn een aantal aanbevelingen te doen welke in de literatuur ondersteund worden met een lage graad van bewijs.

Onderbouwing

Achtergrond

Fundoplications are operative techniques in which the surgeons wrap the fundus of the stomach either completely (360-degrees) or partially (180-degrees or Toupet 270-degrees) around the distal esophagus to create a mechanical barrier. Fundoplications prevent reflux of stomach contents to the esophagus. Most fundoplications are performed laparoscopically, open surgery is rarely necessary. The type of fundoplication is determined by the number of degrees the fundus is folded in a circular direction around the distal esophagus. Until 2000, the Nissen fundoplication (360 degrees) was used as golden standard. However, there is great practice variation whereby the majority of the surgeons opt for a partial fundoplication (Toupet i.e 270 degrees posterior or 180-degrees anterior). A 90-degrees anterior fundoplication is not routinely used. The choice of fundoplication is partially determined by patient-related factors (symptoms and severity of reflux disease, esophageal function) and training and experience of the surgeon.

Conclusies

Laparoscopic anterior fundoplication (LAF, 180-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Health-related quality of life

Visick score

Very low GRADE

The evidence is very uncertain about the effect of 180-degrees fundoplication on Visick score between six and 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Watson, 1999; Baigrie, 2005; Raue, 2011

Very low GRADE

The evidence is very uncertain about the effect of 180-degrees fundoplication on Visick score at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Broeders, 2011; Ludemann, 2005

Low GRADE

The evidence suggests that 180-degrees fundoplication may result in a higher fraction of patients with a favorable Visick score at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Roks, 2017

Dysphagia

Dakkak dysphagia score

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in little to no difference in Dakkak dysphagia score at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Watson, 1999; Baigrie, 2005; Cao, 2012

Very low GRADE

The evidence is very uncertain about the effect of 180-degrees fundoplication on Dakkak dysphagia score at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Broeders, 2011; Ludemann, 2005; Cao, 2012

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in little to no difference in Dakkak dysphagia score at 10 years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Raue, 2011

Events of dysphagia

Very low GRADE

The evidence is very uncertain about the effect of 180-degrees fundoplication on events of dysphagia when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Watson, 1999; Baigrie, 2005; Raue; 2011

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in a decreased number of events of dysphagia at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Broeders, 2011; Ludemann, 2005

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in a decreased number of events of dysphagia at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Cai, 2008

Reflux-control

DeMeester score

Moderate GRADE

The evidence suggests that 180-degrees fundoplication likely results in little to no difference in DeMeester score at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Cao, 2012 and Raue, 2011

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in little to no difference in DeMeester score at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Raue, 2011

GRADE

No literature was found about the effect of 180-degrees fundoplication on DeMeester score at 10 years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

PPI-use

GRADE

No literature was found about the effect of 180-degrees fundoplication on PPI-use at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in an increased number of patients using PPI at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Cao, 2012; Ludemann, 2005

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in an increased number of patients using PPI at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Cai, 2008; Roks, 2017

Bloating

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in fewer patients experiencing bloating at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Raue, 2011; Watson, 1999

Moderate GRADE

The evidence suggests that 180-degrees fundoplication likely results in fewer patients experiencing bloating at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Broeders, 2011; Ludemann, 2005

Low

GRADE

The evidence suggests that 180-degrees fundoplication may result in more patients experiencing bloating at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Cai, 2008; Roks, 2017

Flatulence

Moderate GRADE

The evidence suggests that 180-degrees fundoplication likely results in fewer patients experiencing flatulence at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Watson, 1999

Moderate GRADE

The evidence suggests that 180-degrees fundoplication likely results in fewer patients experiencing flatulence at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Broeders, 2011 and Ludemann, 2005

GRADE

No literature was found about the effect of 180-degrees fundoplication on flatulence at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Laparoscopic Toupet fundoplication (LTF, 270-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Health-related quality of life

Visick score

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in little to no difference in fraction of patients with a favorable Visick score at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Booth, 2008; Chrysos, 2003; Guerin, 2007

Very low

GRADE

The evidence is very uncertain about the effect of 270-degrees fundoplication on Visick score at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Shaw, 2020

GRADE

No literature was found about the effect of 270-degrees fundoplication on Visick score at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Dysphagia

Dakkak dysphagia score

GRADE

No literature was found about the effect of 270-degrees fundoplication on Dakkak dysphagia score at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

GRADE

No literature was found about the effect of 270-degrees fundoplication on Dakkak dysphagia score at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in little to no difference in Dakkak dysphagia score at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Paranyak, 2023

Events of dysphagia

Very low GRADE

The evidence is very uncertain about the effect of 270-degrees fundoplication on events of dysphagia when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Booth, 2008; Chrysos, 2003; Guerin, 2007

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in a decreased number of events of dysphagia at five years when compared to total fundoplication in patients with indication ‘GERD’.

Source: Shaw, 2020

GRADE

No literature was found about the effect of 270-degrees fundoplication on number of events of dysphagia at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Reflux-control

DeMeester score

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in little to no difference in DeMeester score at 12 months when compared to total fundoplication in patients with indication ‘GERD’.

Source: Chrysos, 2003

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in little to no difference in DeMeester score at five years when compared to total fundoplication in patients with indication ‘GERD’.

Source: Shaw, 2010

GRADE

No literature was found about the effect of 270-degrees fundoplication on DeMeester score at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

PPI-use

Very low GRADE

The evidence is very uncertain about the effect of 270-degrees fundoplication on PPI-use at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Sources: Hakanson, 2019; Paranyak, 2023

Low

GRADE

The evidence suggests that 270-degrees fundoplication may result in an increased number of patients using PPI at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Source: Shaw, 2020

GRADE

No literature was found about the effect of 270-degrees fundoplication on PPI-use at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Bloating

GRADE

No literature was found about the effect of 270-degrees fundoplication on bloating at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

GRADE

No literature was found about the effect of 270-degrees fundoplication on bloating at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

GRADE

No literature was found about the effect of 270-degrees fundoplication on bloating score at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Flatulence

GRADE

No literature was found about the effect of 270-degrees fundoplication on flatulence at six to 18 months when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

GRADE

No literature was found about the effect of 270-degrees fundoplication on flatulence at five years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

GRADE

No literature was found about the effect of 270-degrees fundoplication on flatulence at ten years when compared to 360-degrees fundoplication in patients with indication ‘GERD’.

Samenvatting literatuur

Description of studies

Laparoscopic anterior fundoplication (LAF, 180-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Broeders (2013) included eight studies from five original randomized controlled trials (RCTs), which compare LAF versus LNF in patients diagnosed with GERD. In total 458 patients underwent fundoplication procedure, of which n=227 were in LAF group and n=231 in the LNF group. Baseline characteristics are comparable in the included studies. The percentage men included ranged from 37% to 74%. Mean age was not reported in the review, but it ranged from 43 to 59 years. Raue (2011) divided the short gastric vessel in their study. In the trials of Cao (2012) and Watson (1999) patients with esophageal dysmotility were included. These were however equally divided in groups. The included studies were carried out in secondary (or tertiary) care in China, Australia, Germany, Greece, and South Africa. The main outcome measures were among others esophageal acid exposure on pH monitoring (DeMeester score), presence (and severity of) heartburn, presence, and severity of dysphagia (validated modified Dakkak dysphagia score). Secondary outcomes included among others PPI use, inability to belch, bloating, ability to relieve bloating, and increased flatulence. Patients’ satisfactions were measured using Visick score. Articles were included with outcomes after one year (between 6-18 months), at 5 years and after 5 years.

The five included RCT’s were published between 1999 and 2012. The trial from Watson (1999) has a follow-up of 6 months. Data from the trial of Watson (1999) was used also used in other publications to determine long term outcomes; at five years (Ludemann) and at ten years (Cai). The trial from Baigrie (2005) has a follow-up of one year. Data from both Baigrie (2005) and Watson (1999) were used and recalculated in the study from Broeders (2012). Due to the complexity and because data was reused, results were not pooled but are only described in the result section. Watson (1999) and Baigrie (2005) and their follow-up articles are described in more detail below.

Baigrie (2005) performed a double-blind, randomized trial to determine whether LAF can reduce the incidence of postoperative dysphagia, compared to LNF in patients diagnosed with (GERD). In total, 84 patients were randomized to LNF and 79 patients underwent the LAF procedure. In the intervention group 57% were men compared to 58% in the control group. Although the article mentions that groups were well matched for age, this was not reported. Patients were followed-up for three, 12 and 24 months after surgery. Only two patients were lost to follow-up due to inability to contact patients at specific follow-up intervals. There were no cross-overs to open procedures and patients had surgery in accordance with the protocol. Primary outcomes were postoperative dysphagia and control of reflux. Secondary outcomes were, among other outcomes, the Visick score and bloating.

Broeders (2012) made use of the same population as described in Baigrie (2005) and Watson (1999). As short-term and mid-term outcomes were described previously, the aim of this study was to report the 5-year clinical follow-up data. Of the 253 patients described in Watson (1999) and Baigrie (2005), 17 patients were not included in the follow-up of this study.

Roks (2017) made use of the same population as described in Baigrie (2005). As short-term outcomes were described previously, the aim of this study was to report the long-term 12-year clinical follow-up data. Of the 163 patients described in Baigrie (2005) 73 patients were not included in the follow-up of this study. In total, 52 patients were followed-up that underwent Nissen fundoplication, and 38 patients were followed up that underwent 180 anterior fundoplication. Baseline characteristics of these groups were similar after 12 years despite loss to follow-up; in the intervention group 56% was men, compared to 50% in the control group. Data was collected using questionnaire and telephone interviews.

Watson (1999) performed a double-blind, randomized trial in which they aimed to determine whether the routine performance of LAF can reduce the incidence of postoperative dysphagia, or other adverse outcomes, versus LNF. In total, 53 patients were randomized to undergo LNF and 54 to undergo LAF. Both groups were similar for age, sex, weight, height, cigarette and alcohol consumption, incidence of previous abdominal surgery, duration of symptoms and medication consumed before surgery (although the exact numbers were not reported in the paper). Patients were followed-up at one, three or six months after operation and assessed on dysphagia, heartburn, and patient satisfaction.

Ludemann (2005) made use of the same population as described in Watson (1999). As short-term outcomes were described previously, the aim of this study was to report the mid-term 5-year clinical follow-up data. Of the 107 patients described in Watson (1999), six patients were not included in the follow-up of this study.

Cai (2008) made use of the same population as described in Watson (1999). As short-term and mid-term outcomes were described previously, the aim of this study was to report the 10-year clinical follow-up data. Of the 107 patients described in Watson (1999), 18 patients were not included in the follow-up of this study.

Laparoscopic Toupet fundoplication (LTF, 270-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

i (2023) published a systematic review and included ten studies from eight original RCTs, which compare LTF versus LNF in patients diagnosed with GERD. In total, 1212 patients underwent fundoplication procedure, of which n=607 were in the LTF group and n=605 in the LNF group. Baseline characteristics are comparable in the included studies. However, Strate (2008) and Hakanson (2019) show significant differences of baseline characteristics and preoperative complications but did not report this. Furthermore, one study showed differences in wrap with a 1cm wrap in LNF and a 2 cm LTF wrap. The gender distribution was not reported in the review. Mean age was not reported in the review, but it ranged from 44.2 to 61.7 years. The included studies were carried out in England, Greece, Belgium, Sweden, Austria, South Africa, Germany, and China. Both short- and long-term outcomes (>12 months) were reported. The main outcome measures were postoperative reflux recurrence, heartburn, dysphagia, inability to belch, bloating, satisfaction with intervention. Secondary outcome measures were postoperative esophagitis, DeMeester score, use of PPI, lower esophageal sphincter (LOS) pressure. All articles reported long term outcomes (after 12 months) and are therefore included.

The eight included RCT’s were published between 2003 and 2009. These studies reported outcomes with a follow-up period between 12 to 60 months. Two studies only reported after 24 months and were therefore not included (as it exceeded the follow-up period as defined for this module).

Paranyak (2023) performed a double-blind, randomized trial to evaluate the clinical effect of LTF versus LNF on extraesophageal GERD symptoms. In total, 120 were randomized to either undergoing a LNF (n= 60) or LTF (n= 60). The study population consisted of 51 men and 69 women, with a mean age of 52.9 (±11.6) years (range, 29–72 years). No significant differences were observed between the two intervention groups. Patients were followed-up after six, 12 and 24 months. At 24-month follow-up, 13 (21.7%) patients of the LNF group and 16 (26.7) of the LTF group were lost to follow-up. The primary outcome was the elimination of laryngopharyngeal refux (LPR) indicated by normalization of the reflux symptom index (RSI) at 24 months. Secondary outcomes were defined as: change from baseline score in LPR–HRQL questionnaire and discontinuation of PPIs.

Results

Part I: Laparoscopic anterior fundoplication (LAF, 180-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Health-related quality of life - Visick score
Studies included in the LTF scored patients satisfaction used four categories (excellent, good, fair, or poor) to determine the impact on patient satisfaction, and sometimes five categories were used. The categories one or two indicate favorable outcomes for the patients with GERD whereas a higher score indicate unsatisfactory outcomes. The results presented below show the number of patients with favorable Visick score, scoring 1 (excellent) or 2 (very good).

Visick score – at six to 18 months

Three studies described the effect of LAF on health-related QoL using the Visick score between six and 18 months, compared to LNF. Baigrie (2005) and Raue (2011) reported higher number of patients with a favorable Visick score in the LNF group. The differences between the groups were only clinically relevant for Raue (2011). Watson (1999) reported a higher number of patients with a favorable Visick score in the LAF group, although the difference between the groups was borderline clinically relevant (see Table 1). Overall, these studies reported inconclusive results for the differences in number of patients with a favorable Visick score between the groups, at six to 18 months.

Table 1. Favorable Visick score at follow up period of six, 12 and 18 months for patients with GERD, which underwent 180-degree anterior fundoplication or total (360-degree) or Nissen fundoplication.

Study	180-degrees LAF group, n/n (%)	LNF group, n/n (%)	Risk ratio (RR, (95% CI))
6 months (Visick score)
Watson (1999)	43/53 (81%)	39/53 (74%)	RR 1.10 (95 % CI: 0.90 to 1.36)
12 months (Visick score)
Baigrie (2005)	73/79 (92%)	79/83 (96%)	RR 0.97 (95 % CI: 0.90 to 1.05)
18 months (Visick score)
Raue (2011)	21/30 (70%)	25/27 (93%)	RR 0.76 (95 % CI: 0.58 to 0.98)

LAF: anterior fundoplication, LNF: Nissen fundoplication

Visick score – at five years

Two studies reported on the effect of LAF on health-related QoL using the Visick score at five years. Broeders (2011) reported favorable Visick score for 96 out of 116 (82.8%) patients in the LAF group versus 105 out of 129 (81.4%) patients in the LNF group (RR 1.02; 95%CI 0.90 to 1.14). Ludemann (2005) also reported higher number of patients with a favorable Visick score in the LAF group with 42 out of 50 (84%) patients versus 39 out of 51 (76%) in LNF group (RR 1.10; 95%CI 0.90 to 1.33). Hence, both studies did not report clinically relevant differences for health-related QoL, at five years.

Visick score – at ten years

One study reported on the effect on health-related QoL using the Visick score after 10 years. Roks (2017) reported a favorable Visick score (scoring 1 or 2) for 28 out of 38 (74%) patients in the LAF group and 45 out of 50 (90%) patients in the LNF group (RR 0.82; 95%CI 0.66 to 1.01). This study reported a higher number of patients with favorable Visick score in the LNF compared to the 180-degrees LAF group. This difference was considered to be clinically relevant.

Dakkak dysphagia score

Dakkak dysphagia score – at six to 18 months

Three studies reported on the effect of LAF on the mean Dakkak dysphagia score after six to 18 months (see Table 2). All included studies reported lower Dakkak scores in the LAF group. Those differences were however not considered to be clinically relevant.

Table 2. Dakkak dysphagia score at follow-up period of six to 18 months in patients with GERD, which underwent 180-degree anterior fundoplication or total (360-degree) or Nissen fundoplication

Study	180-degrees LAF group, mean Dakkak (SD, or 95%CI)	LNF group, mean Dakkak (SD)	Mean difference (95% CI)
6 months
Watson (1999)	2.1 (95%CI: 0.3 to 3.8)	4.3 (95%CI: 2.4-5.9)	MD -2.20 (95%CI; -4.48 to 0.08)
12 months
Baigrie (2005)	1.0 (95%CI: 0.4 to 1.7)	3.5 (95%CI; 2.0 to 4.9)	MD -2.50 (95%CI; -4.04 to -0.96)
Cao (2012)	6.4 (SD: 2.3)	7.8 (SD: 2.9)	MD -1.40 (95%CI; -2.35 to -0.45)

LAF: anterior fundoplication, LNF: Nissen fundoplication

Dakkak dysphagia score – at five years

Three studies reported on the effect of LAF on the mean Dakkak dysphagia score after five years (see Table 3). All included studies reported lower Dakkak scores in the LAF group. Those differences were however not considered to be clinically relevant.

Table 3. Dakkak dysphagia score at follow up period of five years in patients with GERD, which underwent 180-degree anterior fundoplication or total (360-degree) or Nissen fundoplication.

Study	180-degrees LAF group, mean Dakkak (SD, or 95%CI)	LNF group, mean Dakkak (SD)	Mean difference (95% CI)
5 years
Cao (2012)	5.3 (SD: 1.1)	7.2 (SD: 2.4)	MD -1.90 (95%CI; -2.63 to -1.17)
Broeders (2011)	5.3 (SD: 7.3)	8.8 (SD: 9.5)	MD -3.50 (95%CI; -5.58 to -1.42)
Ludemann (2005)	6.5 (SD not reported)	11.4 (SD not reported)	MD -4.9

LAF: anterior fundoplication, LNF: Nissen fundoplication

Dakkak dysphagia score – at ten years

Two studies reported on the effect of LAF on the mean Dakkak dysphagia score after ten years. Cai (2008) reported a score of 7.8 (SD or 95% CI not reported) in the LAF group (n= 41) compared to 12.0 (SD or 95% CI not reported) in the LNF group (n= 48). In the study by Roks (2017), the mean Dakkak score after 10 years in the LAF group was 2.5 (95% CI 0 - 37.5, n=50) compared to 4.0 (95% CI 0 - 40.0, n=35) in the LNF group. Overall, the studies reported lower Dakkak scores in the LAF group but the differences between the groups were not considered to be clinically relevant.

Events of dysphagia

Events of dysphagia– at six to 18 months
Three studies reported on the effect of LAF on the number of patients with dysphagia after six to 18 months (see Table 4). Two studies, Baigrie (2005) and Watson (1999), reported clinically relevant differences in number of patients with dysphagia in favor of LAF. One study, Raue (2011), reported clinically relevant findings in favor of LNF. Overall, these studies reported inconclusive results for events of dysphagia in favor or against LAF, at six to 18 months.

Table 4. Events of dysphagia at follow up period of six, 12 and 18 months in patients with GERD, which underwent 180-degree anterior fundoplication or total (360-degree) or Nissen fundoplication.

Study	180-degrees LAF group, n/n (%)	LNF group, n/n (%)	Risk ratio (RR, (95%CI))
6 months
Watson (1999)	9/53 (17%)	22/53 (42%)	RR 0.41 (95% CI: 0.21 to 0.80)
12 months
Baigrie (2005)	1/79 (1.3%)	4/83 (4.8%)	RR 0.26 (95% CI: 0.03 to 2.30)
18 months
Raue (2011)	3/30 (10%)	2/27 (7%)	RR 1.35 (95% CI: 0.24 to 7.48)

LAF: anterior fundoplication, LNF: Nissen fundoplication

Events of dysphagia – at five years
Two studies reported on the effect of LAF on the number of patients with dysphagia at five years. Broeders (2011) reported eight out of 38 (21.1%) patients with dysphagia in the LAF group compared to 19 out of 33 (57.6%) patients in the LNF group (RR 0.20; 95% CI 0.07 to 0.56). Ludemann (2005) reported 9 out of 50 (18%) patients with dysphagia in the LAF group versus 14 out of 51 (27%) patients with dysphagia in the LNF group (RR 0.58; 95% CI 0.22 to 1.50). Both studies showed clinically relevant differences in number of patients with dysphagia, which were in favor of LAF, at five years.

Events of dysphagia– at ten years
One study reported on the effect of LAF on the number of patients with dysphagia at ten years. Cai (2008) reported 14 out of 41 (34%) patients with dysphagia in the LAF group versus 25 out of 48 (52%) patients with dysphagia in the LNF group (RR 0.48; 95% CI 0.20 to 1.13). This study showed a clinically relevant difference in number of patients with dysphagia, which was in favor of the LAF group, at ten years.

Reflux control

DeMeester score – at six to 18 months

Two studies reported on the effect of LAF on DeMeester score. Cao (2011) reported a mean DeMeester score at 12 months of 13.4±4.1 in the LAF group (n= 49) compared to 12.0±3.6 in the LNF group (n=47). The mean difference was therefore 1.40 (95% CI -0.11 to 2.91), which was in favor of the LNF group. Raue (2011) reported a median difference in DeMeester score at 18 months of 12 (range 2-42) in the LAF group (n= 30) versus 10 (range of 2 to 41) in the LNF group (n= 27). Hence, these studies did not show a clinically relevant difference in DeMeester score between the groups, at six to 18 months.

DeMeester score – at five years

Cao (2012) reported on the effect of LAF on DeMeester score after five years. Cao (2011) reported a mean (±SD) DeMeester score at five years of 10.2±1.9 in the LAF group (n= 49) compared to 9.5±3.2 in the LNF group (n= 47). The mean difference was therefore 0.70 (95% CI -0.33 to 1.73), in favor of the LNF group. This difference was not considered to be clinically relevant.

DeMeester score – at ten years years

De Meester score – at ten years was not reported.

Proton-pump inhibitor (PPI)-use

PPI-use – at six to 18 months
PPI-use at six to 18 months was not reported.

PPI-use – at five years
Two studies reported on the effect of LAF on the number of patients on PPI therapy at five years. In the study of Cao (2011), four out of 49 (8.2%) patients in the LAF group were on PPI therapy versus four out of 47 (8.5%) in the LNF group (RR 0.96; 95% CI 0.25 to 3.62). This difference was not considered to be clinally relevant and in favor of the LAF group. Ludemann (2005) reported that 2 out of 50 (4%) patients in the LAF group versus 6 out of 51 (12%) patients in the LNF group used PPI (RR 0.34; 0.07 to 1.61). This difference was considered to be clinically relevant and in favor of the LAF group.

PPI-use – at ten years

Two studies reported on the effect of LAF on the number of patients on PPI therapy at ten years. Cai (2008) reported that 11 out of 41 (27%) patients used PPI in the LAF group, compared to 9 out of 48 (19%) patients taking PPI in the LNF group (RR 1.43; 95% CI 0.66 to 3.11). This difference is in favor of the LNF group and was considered to be clinically relevant.

In the study by Roks (2017), PPIs were used by 11 out of 38 patients (29%) in the LAF group and 4 out of 52 patients (8%) in the LNF group, 10 years after the intervention (RR 3.76; 95 % CI 1.30 to 10.92). This difference is in favor of the LNF group and was considered to be clinically relevant.

Bloating
Bloating – at six to 18 months
Two studies reported on the effect of LAF on the number of patients with bloating at six to 18 months. Raue (2011) reported that 2 out of 30 (7%) patients in the LAF group suffered from bloating compared to 3 out of 27 (11%) patients in the LNF group (RR 0.60; 95%CI 0.11 to 3.32). Watson (1999) reported that 10 out of 53 (19%) patients in the LAF group suffered from bloating versus 15 out of 53 (28%) in the LNF group (RR 0.67; 95%CI 0.33 to 1.35). These studies showed clinically relevant difference in number of patients with bloating in favor of LAF, at six to 18 months.

Bloating – at five years

Two studies reported on the effect of LAF on the number of patients with bloating at five years. Broeders (2011) reported that 63 out of 120 (52.5%) patients in the LAF group suffered from bloating compared to 77 out of 132 (58.3%) patients in the LNF group (RR 0.90; 95% CI: 0.72 to 1.12). Ludemann (2005) specifically reported patients with bloating at 5 years. They reported that 22 out of 50 (44%) patients experience bloating in the LAF group versus 38 out of 51 (75%) patients in the LNF group (RR 0.59; 95% CI 0.42 to 0.84). These studies showed clinically relevant differences in number of patients with bloating in favor of LAF, at five years.

Bloating – at ten years

Two studies reported on the effect of LAF on the number of patients with bloating at ten years. Cai (2008) specifically reported about epigastric bloating. They reported that 19 out of 41 (46%) patients in the LAF group suffered from bloating compared to 14 out of 48 (29%) patients in the LNF group (RR 1.59; 95% CI: 0.92 to 2.57). This difference was considered to be clinically relevant and in favor of the LNF group.

In the study by Roks (2017), in total 20 out of 38 patients (53%) experienced bloating in the LAF group and 21 out of 52 patients (40%) in the LNF group, 10 years after the intervention (RR 1.30; 95% CI: 0.83 to 2.04). This difference was considered to be clinically relevant and in favor of the LNF group.

Flatulence

Flatulence – at six to 18 months

One study reported on the effect of LAF on the number of patients with flatulence at six months. Watson (1999) reported that 15 out of 53 (28%) patients in the LAF group versus 26 out of 52 (49%) patients in the LNF group suffered from flatulence (RR 0.58; 95% CI: 0.35 to 0.96). This difference was considered to be clinically relevant and in favor of the LAF group.

Flatulence – at five years
Two studies reported on the effect of LAF on the number of patients with flatulence at five years. Broeders (2011) reported that 57 out of 120 (51.8%) in the LAF group versus 79 out of 119 (66.4%) in the LNF group suffer from flatulence (RR 0.46; 95% CI: 0.27 to 0.77). Ludemann (2005) reported 31 out of 50 (62%) patients with flatulence in the LAF group versus 41 out of 51 (80%) in the LNF group (RR 0.40; 95% CI: 0.16 to 0.98). These differences were considered to be clinically relevant and in favor of the LAF group.

Flatulence – at ten years

Flatulence at ten years was not reported.

Laparoscopic Toupet fundoplication (LTF, 270-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Visick score – at 12 months

Three studies described the effect of LTF on health-related QoL at 12 months (see Table 5). The study of Chrysos (2003) reported higher fraction of patients with favorable Visick socre in the LTF group, but this difference was considered to be not clinically relevant. Booth (2008) and Guerin (2007) reported comparable number of patients with favorable Visick scores in the two groups.

Table 5. Favorable Visick score at follow up period of 12 months for patients with GERD, which underwent laparoscopic Toupet fundoplication or total (360-degree) or Nissen fundoplication.

Study	LTF group, n/n (%)	LNF group, n/n (%)	Risk ratio (95% CI)
12 months (Visick score)
Booth (2008)	53/58 (91%)	54/59 (92%)	RR 1.00 (95% CI: 0.90 to 1.12)
12 months (4-categories)
Chrysos (2003)	17/19 (89%)	13/14 (93%)	RR 1.04 (95% CI: 0.84 to 1.28)
Guerin (2007)	56/57 (98%)	63/64 (98%)	RR 1.00 (95% CI: 0.96 to 1.05)

LTF: Laparoscopic Toupet fundoplication, LNF: Nissen fundoplication

Visick score – at five years

One study reported on the effect of LTF on health-related QoL using the Visick score at five years. Shaw (2020) reported favorable Visick scores for 33 out of 48 (69%) patients in the LTF group versus 34 out of 47 (72%) patients in the LNF group (RR 1.05; 95% CI: 0.81 to 1.36). This difference was in favor of the LTF group but not considered to be clinically relevant.

Visick score – at ten years

Visick score at ten years was not reported

Dakkak dysphagia score

Dakkak dysphagia score – at six to 18 months

Dakkak dysphagia score at six to 18 months was not reported.

Dakkak dysphagia score – at five years

Dakkak dysphagia score at five years was not reported.

Dakkak dysphagia score – at ten years

One study reported on the effect of the LTF on Dakkak dysphagia score at 10 years. Paranyak (2023) reported a mean score of 2.5 (0 - 37.5) in the LTF group (n= 50) compared to 4.0 (0 -40) in the LNF group (n= 35). Mean difference was 1.5, which was in favor of the LTF group. This difference was not considered to be clinically relevant.

Events of dysphagia

Events of dysphagia– at 12 months

Three studies reported on the effect of LTF on the number of patients with dysphagia at 12 months (see Table 6). One study, Booth (2008), reported clinically relevant differences in number of patients with dysphagia, which was in favor of the LTF group. Two studies (Chrysos, 2003 and Guerin, 2007), reported clinically relevant findings in favor of LNF. Overall, these studies indicated inconclusive results for the number of patients experiencing dysphagia, at 12 months.

Table 6. Events of dysphagia at follow up period of 12 months in patients with GERD, which underwent laparoscopic Toupet fundoplication or total (360-degree) or Nissen fundoplication.

Study (12 months)	LTF group, n/n (%)	LNF group, n/n (%)	Risk ratio (95% CI)
Booth (2008)	5/58 (8.6%)	16/59 (27%)	RR 3.15 (95% CI: 1.23 to 8.02)
Chrysos (2003)	3/19 (16%)	2/14 (14%)	RR 0.90 (95% CI: 0.17 to 4.71)
Guerin (2007)	4/57(7%)	3/64(4.7%)	RR 0.67 (95% CI: 0.16 to 2.68)

LTF: Laparoscopic Toupet fundoplication, LNF: Nissen fundoplication

Events of dysphagia – at five years
One study reported on the effect of LTF on the number of patients with dysphagia at five years. Shaw (2010) reported one out of 48 (2%) patient experienced dysphagia in the LTF group compared to 3 out of 37 (6.4%) patients in the LNF group (RR 3.06; 95% CI: 0.33 to 28.4). This difference was considered to be clinically relevant and in favor of the LTF group.

Events of dysphagia– at ten years
Events of dysphagia at ten years was not reported.

Reflux control

DeMeester score – at 12 months
Two studies reported on the effect of LTF on DeMeester score at 12 months. In the study of Chrysos (2003) the mean score was 12±4 in the LTF group versus 14±5 in the LNF group (MD 2.0; 95% CI -1.19 to 5.18). The study of Koch (2013) reported a mean score of 6.94±13.72 in the LTF group and 7.99±22.3 in the LNF group (MD 1.05; 95%CI -5.88 to 7.98). Overall, these studies indicated lower de Meester scores in the LTF group, but the differences were not considered to be clinically relevant.

DeMeester score – at five years

One study reported on the effect of LTF on DeMeester score at five years. In the study of Shaw (2010) the mean score was 10.4±21.6 in the LTF group versus 9.8±24.3 in the LNF group (MD -0.52; 95% CI -10.36 to 9.32). Mean difference was in favor of the LNF group, but was considered to be not clinically relevant.

DeMeester score – at ten years years
De Meester score at ten years was not reported.

Proton-pump inhibitor (PPI)-use

PPI-use – at 12 months
Two studies reported on the effect of LTF on the number of patients on PPI therapy at 12 months. In the study of Hakanson (2019), 35 out of 228 (15%) patients in the LTF group were on PPI therapy versus 37 out of 227 (16%) in the LNF group (RR 0.95; 95% CI 0.62 to 1.46). This difference is in favor of the LTF group. In the study by Paranyak (2023), 10 out of 60 (22.7%) patients in the LTF group were on PPI therapy versus 8 out of 60 (17%) in the LNF group (RR 1.25; 95% CI: 0.53 to 2.95). This difference is in favor of the LTF group. Overall, these results showed no clinically relevant differences between the LTF or LNF group, at 12 months.

PPI-use – at five years
One study reported on the effect of LTF on the number of patients on PPI therapy at 5 years. In the study of Shaw (2010), 5 out of 48 (10%) patients in the LTF group were on PPI therapy versus 7 out of 47 (15%) in the LNF group (RR 1.43; 95% CI 0.49 to 4.19). This difference is in favor of the LTF group and considered to be clinically relevant.

PPI-use – at ten years

PPI-use at ten years was not reported.

Bloating
Bloating – at 12 months
Three studies reported on the effect of LTF on the number of patients experiencing bloating at 12 months (see Table 7). All of the studies reported clinically significant differences between the group, which were in favor of LTF.

Table 7. Events of gas bloating at follow up period of 12 months in patients with GERD, which underwent laparoscopic Toupet fundoplication or total (360-degree) or Nissen fundoplication.

Study (12 months)	LTF group, n/n (%)	LNF group, n/n (%)	Risk ratio (95% CI)
Booth (2008)	6/58 (10%)	11/59 (19%)	RR 1.80 (95% CI: 0.71 to 4.55)
Chrysos (2003)	3/19 (16%)	3/14 (21%)	RR 1.36 (95% CI: 0.32 to 5.75)
Guerin (2007)	8/57 (14%)	12/64 (19%)	RR 1.34 (95% CI: 0.59 to 3.03)

LTF: Laparoscopic Toupet fundoplication, LNF: Nissen fundoplication

Bloating – at five years

Bloating at five years was not reported.

Bloating – at ten years
Bloating at ten years was not reported.

Flatulence

Flatulence – at six to 18 months
Flatulence at six to 18 months was not reported.

Flatulence – at five years
Flatulence at five years was not reported.

Flatulence – at ten years
Flatulence at ten years was not reported.

Level of evidence of the literature

Part II: Laparoscopic anterior fundoplication (LAF, 180-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Visick score

Visick score (six to 18 mo)

The level of evidence regarding the outcome measure Visick score at six to 18 months was downgraded by three levels to very low because of inconclusive results (-1, inconsistency) and wide confidence intervals crossing one border (-2, imprecision).

Visick score (five y)

The level of evidence regarding the outcome measure Visick score at five years was downgraded by three levels to very low because of because of the risk of bias due to the use of self-reported questionnaires (-1, risk of bias), inconclusive results (-1, inconsistency) and wide confidence intervals crossing two borders (-1, imprecision).

Visick score (ten y)

The level of evidence regarding the outcome measure Visick score at ten years was downgraded by two levels to low because of the risk of bias due to the use of self-reported questionnaires (-1, risk of bias) and small population size (-1, imprecision).

Dakkak dysphagia score
Dakkak dysphagia score (six to 18 mo)

The level of evidence regarding the outcome measure Dakkak dysphagia score at six to 18 months was downgraded by two levels to low because of very wide confidence intervals crossing two borders (-2, imprecision).

Dakkak dysphagia score (five y)

The level of evidence regarding the outcome measure Dakkak dysphagia score at five years was downgraded by three levels to very low because of risk of bias in study design (-1, incomplete reporting) and very wide confidence intervals crossing two borders (-2, imprecision).

Dakkak dysphagia score (ten y)

The level of evidence regarding the outcome measure Dakkak dysphagia score at ten years was downgraded by two levels to low because of risk of bias in study design (-1, incomplete reporting) and wide confidence intervals (-1, imprecision).

Events of dysphagia
Events of dysphagia (six to 18 mo)

The level of evidence regarding the outcome measure Events of dysphagia at six to 18 months was downgraded by three levels to very low because of inconclusive results (-1, inconsistency) and very wide confidence intervals crossing two borders (-2, imprecision).

Events of dysphagia (five y)
The level of evidence regarding the outcome measure Events of dysphagia at five years was downgraded by two levels to low because of wide confidence intervals crossing two borders (-2, imprecision).

Events of dysphagia (ten y)

The level of evidence regarding the outcome measure Events of dysphagia at ten years was downgraded by two levels to low because of very wide confidence intervals crossing two borders (-2, imprecision).

DeMeester score
DeMeester score (six to 18 mo)

The level of evidence regarding the outcome measure DeMeester score at six to 18 months was downgraded by one level to moderate because of wide confidence intervals (-1, imprecision).

DeMeester score (five y)

The level of evidence regarding the outcome measure DeMeester score at five years was downgraded by two levels to low because of the small study population (-2, imprecision).

DeMeester score (ten y)

The level of evidence regarding the outcome measure DeMeester score at ten years could not be determined, since this outcome was not reported.

PPI-use
PPI-use score (six to 18 mo)

The level of evidence regarding the outcome measure PPI-use at six to 18 months could not be determined, since this outcome was not reported.

PPI-use score (five y)

The level of evidence regarding the outcome measure PPI-use at five years was downgraded by three levels to low because of very wide confidence intervals crossing two borders (-2, imprecision).

PPI-use score (ten y)

The level of evidence regarding the outcome measure PPI-use at ten years was downgraded by three levels to low because of because of inconclusive results (-1, inconsistency) and very wide confidence intervals crossing two borders (-1, imprecision).

Bloating
Bloating (six to 18 mo)

The level of evidence regarding the outcome measure bloating at six to 18 months

was downgraded by two levels to low because very wide confidence intervals crossing two borders (-2, imprecision).

Bloating (five y)

The level of evidence regarding the outcome measure bloating at five years

was downgraded by one level to moderate because of wide confidence intervals crossing one border (-1, imprecision)

Bloating (ten y)

The level of evidence regarding the outcome measure bloating at ten years

was downgraded by two levels to low because of wide confidence intervals crossing two borders (-2, imprecision)

Flatulence
Flatulence (six to 18 mo)

The level of evidence regarding the outcome measure flatulence at six to 18 months

was downgraded by one level to moderate because of wide confidence interval crossing one border (-1, imprecision)

Flatulence (five y)

The level of evidence regarding the outcome measure flatulence at five years

was downgraded by was downgraded by one level to moderate because of wide confidence interval crossing one border (-1, imprecision)

Flatulence (ten y)

The level of evidence regarding the outcome measure flatulence at ten years could not be determined, since this outcome was not reported.

Laparoscopic Toupet fundoplication (LTF, 270-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication)

Visick score

Visick score (six to 18mo)

The level of evidence regarding the outcome measure Visick score at six to 18 months was downgraded by two levels to low because of the risk of bias due to the use of self-reported questionnaires (-1, risk of bias) and wide confidence intervals crossing one border (-1, imprecision).

Visick score (five y)

The level of evidence regarding the outcome measure Visick score at five years was downgraded by three levels to very low because of the risk of bias due to the use of self-reported questionnaires (-1, risk of bias) and the small study population (-2, imprecision).

Visick score (ten y)

The level of evidence regarding the outcome measure Visick score at ten years could not be determined, since this outcome was not reported.

Dakkak dysphagia score

Dakkak dysphagia score (six to 18 mo)

The level of evidence regarding the outcome measure Dakkak dysphagia score at six to 18 months could not be determined since this outcome was not reported.

Dakkak dysphagia score (five y)

The level of evidence regarding the outcome measure Dakkak dysphagia score at five years could not be determined since this outcome was not reported.

Dakkak dysphagia score (ten y)

The level of evidence regarding the outcome measure Dakkak dysphagia score at ten years was downgraded by one level to moderate because of the small study population (-2, imprecision).

Events of dysphagia

Events of dysphagia (six to 18 mo)

The level of evidence regarding the outcome measure Events of dysphagia at six to 18 months was downgraded by three levels to very low because of inconclusive results (-2, inconsistency) and wide confidence intervals crossing the borders for clinical relevance (-1, imprecision).

Events of dysphagia (five y)
The level of evidence regarding the outcome measure Events of dysphagia at five years was downgraded by two levels to low because of the wide confidence intervals crossing the borders for clinical relevance (-2, imprecision).

Events of dysphagia (ten y)

The level of evidence regarding the outcome measure Events of dysphagia at ten years could not be determined, since this outcome was not reported.

DeMeester score

DeMeester score (6-18 mo)

The level of evidence regarding the outcome measure DeMeester score at six to 18 months was downgraded by two levels to low because of very wide confidence intervals (-2, imprecision).

DeMeester score (five y)

The level of evidence regarding the outcome measure DeMeester score at five years was downgraded by was downgraded by two levels to low because of very wide confidence intervals (-2, imprecision).

DeMeester score (ten y)

The level of evidence regarding the outcome measure DeMeester score at ten years could not be determined, since this outcome was not reported.

PPI-use

PPI-use (6-18 mo)

The level of evidence regarding the outcome measure PPI-use at six to 18 months was downgraded by three levels to very low because of inconclusive results (-1, inconsistency) and very wide confidence intervals crossing two borders (-2, imprecision).

PPI-use (five y)

The level of evidence regarding the outcome measure PPI-use at five years was downgraded by two levels to low because of very wide confidence intervals crossing two borders (-2, imprecision).

PPI-use (ten y)

The level of evidence regarding the outcome measure PPI-use at ten years could not be determined since this outcome was not reported.

Bloating

Bloating (six to 18 mo)

The level of evidence regarding the outcome measure bloating at six to 18 months

was downgraded by two levels to low because of wide confidence intervals crossing both borders of clinical relevance (-2, imprecision).

Bloating (five y)

The level of evidence regarding the outcome measure bloating at five years could not be determined since this outcome was not reported.

Bloating (ten y)

The level of evidence regarding the outcome measure bloating at ten years could not be determined since this outcome was not reported.

Flatulence

Flatulence (six to 18 mo)

The level of evidence regarding the outcome measure flatulence at six to 18 months could not be determined since this outcome was not reported.

Flatulence (five y)

The level of evidence regarding the outcome measure flatulence at five years could not be determined since this outcome was not reported.

Flatulence (ten y)

The level of evidence regarding the outcome measure flatulence at ten years could not be determined since this outcome was not reported.

Zoeken en selecteren

A systematic review of the literature was performed to answer the following question: what are (un)favorable effects of partial (180-degrees anterior or Toupet) fundoplication compared to total or Nissen fundoplication in adults with gastroesophageal reflux disease (GERD)?

P (Patients) adults with GERD

I (Intervention) partial 180-degrees (anterior) fundoplication (LAF) or Toupet fundoplication (LTF)

C (Comparison) Total or Nissen fundoplication (LNF)

O (Outcomes) health-related quality of life (HRQOL); dysphagia; refluxcontrol, proton-pump inhibitor (PPI) use; bloating, flatulence.

Relevant outcome measures

The guideline development group considered health-related quality of life as a critical outcome measure for decision making; and dysphagia, refluxcontrol, proton pump inhibitor (PPI) use, bloating and flatulence as an important outcome measure for decision making. A short-term (follow-up after six to 18 months), mid-term (follow-up after five years) and long-term outcome (follow-up after ten years) was defined for each outcome.

The working group defined the outcomes measures as follows:

Health-related Quality of Life (QoL) score measured after one year by a validated questionnaire, in particular:

Visick score: which measures QoL based on four (1: complete resolution, 4: worsened) or five categories (1: excellent, 5: unsatisfactory).

Dysphagia outcome as:

Dakkak dysphagia score: 45-point scale questionnaire. According to the official publication and validation (Dakkak 1992) on the Dakkak score, higher scores indicate better outcomes (no difficulty in swallowing). However, recent and included studies define higher points as unfavorable outcomes with respect to swallowing food and severity of dysphagia (45= severe dysphagia).
Events of dysphagia (number of patients presenting with dysphagia).

Refluxcontrol

Ph Measurement: DeMeester-score with a score > 14.7 indicating reflux.

The working group did not define the other outcome measures listed above but used the definitions used in the studies.

The working group defined clinical relevance boundaries as follows:

Health-related QoL:

Visick score: 0.91 ≥ RR ≥1.1.

Dakkak dysphagia score: difference of 10 or higher indicating clinically relevant dysphagia.
Dysphagia events: 0.91 ≥ RR ≥1.1.
Refluxcontrol

pH-measurement: DeMeester score (DSM): difference of five or higher indicating clinically relevant improvement in refluxcontrol.

PPI use: 0.91 ≥ RR ≥1.1.
Bloating events: 0.91 ≥ RR ≥1.1.
Flatulence events: 0.91 ≥ RR ≥1.1.

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until the 4th of August 2023. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 279 hits. Studies were selected based on the following criteria:

Systematic review (searched in at least two databases, and detailed search strategy, risk of bias assessment and results of individual studies available) or randomized controlled trial.
Comparing laparoscopic anterior fundoplication (LAF, 180-degrees posterior fundoplication) and laparoscopic Toupet fundoplication (LTF, 270-degrees posterior fundoplication) versus laparoscopic Nissen fundoplication (LNF, 360-degrees total fundoplication).
Included patients with gastroesophageal reflux disease (GERD).
Patients aged ≥ 16 years.
At least one of the following outcomes: health-related quality of life (using Visick score), dysphagia (Dakkak dysphagia score or number of events), refluxcontrol, proton-pump inhibitor (PPI) use; bloating, flatulence.
Follow-up period minimally 1 year.
Full-text English language publication.

74 studies were initially selected based on title and abstract screening. After reading the full text, 68 studies were excluded (see the table with reasons for exclusion under the tab Methods). Due to the large amount of literature available, in the LAF versus LNF and LTF versus LNF comparison, the latest systematic review (SR) was selected for this module. RCT’s published after the publication date of the SR, were included as well.

Referenties

Baigrie RJ, Cullis SN, Ndhluni AJ, Cariem A. Randomized double-blind trial of laparoscopic Nissen fundoplication versus anterior partial fundoplication. Br J Surg. 2005 Jul;92(7):819-23. doi: 10.1002/bjs.4803. PMID: 15898129.
Booth MI, Stratford J, Jones L, Dehn TC. Randomized clinical trial of laparoscopic total (Nissen) versus posterior partial (Toupet) fundoplication for gastro-oesophageal reflux disease based on preoperative oesophageal manometry. Br J Surg. 2008 Jan;95(1):57-63. doi: 10.1002/bjs.6047. PMID: 18076018.
Broeders JA, Roks DJ, Jamieson GG, Devitt PG, Baigrie RJ, Watson DI. Five-year outcome after laparoscopic anterior partial versus Nissen fundoplication: four randomized trials. Ann Surg. 2012 Apr;255(4):637-42. doi: 10.1097/SLA.0b013e31824b31ad. PMID: 22418004.
Broeders JA, Roks DJ, Ahmed Ali U, Watson DI, Baigrie RJ, Cao Z, Hartmann J, Maddern GJ. Laparoscopic anterior 180-degree versus nissen fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis of randomized clinical trials. Ann Surg. 2013 May;257(5):850-9. doi: 10.1097/SLA.0b013e31828604dd. PMID: 23470572.
Broeders JA, Broeders EA, Watson DI, Devitt PG, Holloway RH, Jamieson GG. Objective outcomes 14 years after laparoscopic anterior 180-degree partial versus nissen fundoplication: results from a randomized trial. Ann Surg. 2013 Aug;258(2):233-9. doi: 10.1097/SLA.0b013e318278960e. PMID: 23207247.
Cai W, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG. Ten-year clinical outcome of a prospective randomized clinical trial of laparoscopic Nissen versus anterior 180( degrees ) partial fundoplication. Br J Surg. 2008 Dec;95(12):1501-5. doi: 10.1002/bjs.6318. PMID: 18942055.
Chrysos E, Athanasakis E, Pechlivanides G, Tzortzinis A, Mantides A, Xynos E. The effect of total and anterior partial fundoplication on antireflux mechanisms of the gastroesophageal junction. Am J Surg. 2004 Jul;188(1):39-44. doi: 10.1016/j.amjsurg.2003.10.023. PMID: 15219483.
Cao Z, Cai W, Qin M, Zhao H, Yue P, Li Y. Randomized clinical trial of laparoscopic anterior 180° partial versus 360° Nissen fundoplication: 5-year results. Dis Esophagus. 2012 Feb;25(2):114-20. doi: 10.1111/j.1442-2050.2011.01235.x. Epub 2011 Aug 24. PMID: 21883656.
Lee Y, Tahir U, Tessier L, Yang K, Hassan T, Dang J, Kroh M, Hong D. Long-term outcomes following Dor, Toupet, and Nissen fundoplication: a network meta-analysis of randomized controlled trials. Surg Endosc. 2023 Jul;37(7):5052-5064. doi: 10.1007/s00464-023-10151-5. Epub 2023 Jun 12. PMID: 37308760.
Li G, Jiang N, Chendaer N, Hao Y, Zhang W, Peng C. Laparoscopic Nissen Versus Toupet Fundoplication for Short- and Long-Term Treatment of Gastroesophageal Reflux Disease: A Meta-Analysis and Systematic Review. Surg Innov. 2023 Dec;30(6):745-757. doi: 10.1177/15533506231165829. Epub 2023 Mar 30. PMID: 36998190; PMCID: PMC10656788.
Ludemann R, Watson DI, Jamieson GG, Game PA, Devitt PG. Five-year follow-up of a randomized clinical trial of laparoscopic total versus anterior 180 degrees fundoplication. Br J Surg. 2005 Feb;92(2):240-3. doi: 10.1002/bjs.4762. PMID: 15609384.
Markar S, Andreou A, Bonavina L, Florez ID, Huo B, Kontouli KM, Low DE, Mavridis D, Maynard N, Moss A, Pera M, Savarino E, Siersema P, Sifrim D, Watson DI, Zaninotto G, Antoniou SA. UEG and EAES rapid guideline: Update systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on surgical management of GERD. United European Gastroenterol J. 2022 Nov;10(9):983-998. doi: 10.1002/ueg2.12318. Epub 2022 Oct 5. PMID: 36196591; PMCID: PMC9731663.
Paranyak M, Patel R. A prospective randomized trial on laparoscopic total vs partial fundoplication in patients with atypical symptoms of gastroesophageal reflux disease. Langenbecks Arch Surg. 2023 Jul 8;408(1):269. doi: 10.1007/s00423-023-03013-0. PMID: 37421502.
Raue W, Ordemann J, Jacobi CA, Menenakos C, Buchholz A, Hartmann J. Nissen versus Dor fundoplication for treatment of gastroesophageal reflux disease: a blinded randomized clinical trial. Dig Surg. 2011;28(1):80-6. doi: 10.1159/000323630. Epub 2011 Feb 4. PMID: 21293136.
Roks DJ, Broeders JA, Baigrie RJ. Long-term symptom control of gastro-oesophageal reflux disease 12 years after laparoscopic Nissen or 180° anterior partial fundoplication in a randomized clinical trial. Br J Surg. 2017 Jun;104(7):852-856. doi: 10.1002/bjs.10473. Epub 2017 Feb 3. PMID: 28158901.
Rudolph-Stringer V, Bright T, Irvine T, Thompson SK, Devitt PG, Game PA, Jamieson GG, Watson DI. Randomized Trial of Laparoscopic Nissen Versus Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15 to 20 years. Ann Surg. 2022 Jan 1;275(1):39-44. doi: 10.1097/SLA.0000000000004643. PMID: 33214480.
Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section. Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7. doi: 10.1001/archsurg.139.11.1160. PMID: 15545560.

Evidence tabellen

Table of excluded studies

Reference	Reason for exclusion
Rausa E, Ferrari D, Kelly ME, Aiolfi A, Vitellaro M, Rottoli M, Bonitta G, Bona D. Efficacy of laparoscopic Toupet fundoplication compared to endoscopic and surgical procedures for GERD treatment: a randomized trials network meta-analysis. Langenbecks Arch Surg. 2023 Jan 21;408(1):52. doi: 10.1007/s00423-023-02774-y. PMID: 36680602.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Du X, Hu Z, Yan C, Zhang C, Wang Z, Wu J. A meta-analysis of long follow-up outcomes of laparoscopic Nissen (total) versus Toupet (270°) fundoplication for gastro-esophageal reflux disease based on randomized controlled trials in adults. BMC Gastroenterol. 2016 Aug 2;16(1):88. doi: 10.1186/s12876-016-0502-8. PMID: 27484006; PMCID: PMC4969978.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Tian ZC, Wang B, Shan CX, Zhang W, Jiang DZ, Qiu M. A Meta-Analysis of Randomized Controlled Trials to Compare Long-Term Outcomes of Nissen and Toupet Fundoplication for Gastroesophageal Reflux Disease. PLoS One. 2015 Jun 29;10(6):e0127627. doi: 10.1371/journal.pone.0127627. PMID: 26121646; PMCID: PMC4484805.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Tan G, Yang Z, Wang Z. Meta-analysis of laparoscopic total (Nissen) versus posterior (Toupet) fundoplication for gastro-oesophageal reflux disease based on randomized clinical trials. ANZ J Surg. 2011 Apr;81(4):246-52. doi: 10.1111/j.1445-2197.2010.05481.x. Epub 2010 Sep 16. PMID: 21418467.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Broeders JA, Mauritz FA, Ahmed Ali U, Draaisma WA, Ruurda JP, Gooszen HG, Smout AJ, Broeders IA, Hazebroek EJ. Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-oesophageal reflux disease. Br J Surg. 2010 Sep;97(9):1318-30. doi: 10.1002/bjs.7174. PMID: 20641062.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Krysztopik RJ, Jamieson GG, Devitt PG, Watson DI. A further modification of fundoplication. 90 degrees anterior fundoplication. Surg Endosc. 2002 Oct;16(10):1446-51. doi: 10.1007/s00464-002-8801-2. Epub 2002 Jun 27. PMID: 12085141.	Wrong intervention: 90-degrees anterior fundoplication.
Spence GM, Watson DI, Jamiesion GG, Lally CJ, Devitt PG. Single center prospective randomized trial of laparoscopic Nissen versus anterior 90 degrees fundoplication. J Gastrointest Surg. 2006 May;10(5):698-705. doi: 10.1016/j.gassur.2005.10.003. PMID: 16713542.	Wrong intervention: 90-degrees anterior fundoplication.
Qin M, Ding G, Yang H. A clinical comparison of laparoscopic Nissen and Toupet fundoplication for gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech A. 2013 Jul;23(7):601-4. doi: 10.1089/lap.2012.0485. Epub 2013 Apr 24. PMID: 23614820.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Analatos A, Håkanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Clinical Outcomes of a Laparoscopic Total vs a 270° Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805. PMID: 35442430; PMCID: PMC9021984.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Djerf P, Montgomery A, Hallerbäck B, Håkansson HO, Johnsson F. One- and ten-year outcome of laparoscopic anterior 120° versus total fundoplication: a double-blind, randomized multicenter study. Surg Endosc. 2016 Jan;30(1):168-77. doi: 10.1007/s00464-015-4177-y. Epub 2015 Apr 1. PMID: 25829064.	Wrong intervention: 120-degrees vs. Nissen fundoplication.
Håkanson BS, Lundell L, Bylund A, Thorell A. Comparison of Laparoscopic 270° Posterior Partial Fundoplication vs Total Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2019 Jun 1;154(6):479-486. doi: 10.1001/jamasurg.2019.0047. PMID: 30840057; PMCID: PMC6583844.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Koch OO, Antoniou SA, Kaindlstorfer A, Asche KU, Granderath FA, Pointner R. Effectiveness of laparoscopic total and partial fundoplication on extraesophageal manifestations of gastroesophageal reflux disease: a randomized study. Surg Laparosc Endosc Percutan Tech. 2012 Oct;22(5):387-91. doi: 10.1097/SLE.0b013e31825efb5b. PMID: 23047378.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Nijjar RS, Watson DI, Jamieson GG, Archer S, Bessell JR, Booth M, Cade R, Cullingford GL, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin IJ, Nathanson LK, Windsor JA; International Society for the Diseases of the Esophagus-Australasian Section. Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2010 Jun;145(6):552-7. doi: 10.1001/archsurg.2010.81. PMID: 20566975.	Wrong intervention: 90 anterior fundoplication.
Kamolz, T., Granderath, F., Bammer, T., Wykypiel Jr., H., & Pointner, R. (2002). “Floppy” Nissen vs. Toupet Laparoscopic Fundoplication: Quality of Life Assessment in a 5-Year Follow-Up (Part 2). Endoscopy, 34, 917 - 922.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Hagedorn C, Lönroth H, Rydberg L, Ruth M, Lundell L. Long-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: results of a randomized clinical trial. J Gastrointest Surg. 2002 Jul-Aug;6(4):540-5. doi: 10.1016/s1091-255x(02)00037-9. PMID: 12127119.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Hopkins RJ, Irvine T, Jamieson GG, Devitt PG, Watson DI. Long-term follow-up of two randomized trials comparing laparoscopic Nissen 360° with anterior 90° partial fundoplication. Br J Surg. 2020 Jan;107(1):56-63. doi: 10.1002/bjs.11327. Epub 2019 Sep 10. PMID: 31502659.	Wrong intervention: 90 anterior fundoplication.
Granderath FA, Kamolz T, Granderath UM, Pointner R. Gas-related symptoms after laparoscopic 360 degrees Nissen or 270 degrees Toupet fundoplication in gastrooesophageal reflux disease patients with aerophagia as comorbidity. Dig Liver Dis. 2007 Apr;39(4):312-8. doi: 10.1016/j.dld.2006.11.011. Epub 2007 Feb 15. PMID: 17306636.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Grommes J, Binnebösel M, Klink CD, von Trotha KT, Junge K, Jansen M. Surgical technique for gastroesophageal reflux disease. J Invest Surg. 2010 Oct;23(5):273-9. doi: 10.3109/08941939.2010.496034. PMID: 20874483.	Wrong study design: prospective study without randomization.
Mickevicius A, Endzinas Z, Kiudelis M, Jonaitis L, Kupcinskas L, Maleckas A, Pundzius J. Influence of wrap length on the effectiveness of Nissen and Toupet fundoplication: a prospective randomized study. Surg Endosc. 2008 Oct;22(10):2269-76. doi: 10.1007/s00464-008-9852-9. Epub 2008 Apr 9. PMID: 18398651.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Hajibandeh S, Hajibandeh S, Pugh M, Winters D, Hobbs N, Tarazi M, Panda N, Dalmia S, Mansour M, Malik S. Impact of Toupet Versus Nissen Fundoplication on Dysphagia in Patients With Gastroesophageal Reflux Disease and Associated Preoperative Esophageal Dysmotility: A Systematic Review and Meta-Analysis. Surg Innov. 2018 Sep 12:1553350618799549. doi: 10.1177/1553350618799549. Epub ahead of print. PMID: 30205785.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Strate U, Emmermann A, Fibbe C, Layer P, Zornig C. Laparoscopic fundoplication: Nissen versus Toupet two-year outcome of a prospective randomized study of 200 patients regarding preoperative esophageal motility. Surg Endosc. 2008 Jan;22(1):21-30. doi: 10.1007/s00464-007-9546-8. Epub 2007 Nov 20. PMID: 18027055.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Zornig C, Strate U, Fibbe C, Emmermann A, Layer P. Nissen vs Toupet laparoscopic fundoplication. Surg Endosc. 2002 May;16(5):758-66. doi: 10.1007/s00464-001-9092-8. Epub 2002 Feb 8. PMID: 11997817.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Watson DI, Devitt PG, Smith L, Jamieson GG. Anterior 90° partial vs Nissen fundoplication--5 year follow-up of a single-centre randomised trial. J Gastrointest Surg. 2012 Sep;16(9):1653-8. doi: 10.1007/s11605-012-1920-8. Epub 2012 May 26. PMID: 22639376.	Wrong intervention: 90 anterior fundoplication.
Wang B, Zhang W, Liu S, Du Z, Shan C, Qiu M. A Chinese randomized prospective trial of floppy Nissen and Toupet fundoplication for gastroesophageal disease. Int J Surg. 2015 Nov;23(Pt A):35-40. doi: 10.1016/j.ijsu.2015.08.074. Epub 2015 Sep 7. PMID: 26360740.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Woodcock SA, Watson DI, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford GL, Devitt PG, Fletcher DR, Hurley J, Jamieson GG, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society fir Disease of the Esophagus - Australasian Section. Quality of life following laparoscopic anterior 90 s versus Nissen fundoplication: results from a multicenter randomized trial. World J Surg. 2006 Oct;30(10):1856-63. doi: 10.1007/s00268-005-0623-7. PMID: 16983477.	Wrong intervention: 90 anterior fundoplication.
Guérin E, Bétroune K, Closset J, Mehdi A, Lefèbvre JC, Houben JJ, Gelin M, Vaneukem P, El Nakadi I. Nissen versus Toupet fundoplication: results of a randomized and multicenter trial. Surg Endosc. 2007 Nov;21(11):1985-90. doi: 10.1007/s00464-007-9474-7. PMID: 17704884.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Mardani J, Lundell L, Engström C. Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up. Ann Surg. 2011 May;253(5):875-8. doi: 10.1097/SLA.0b013e3182171c48. PMID: 21451393.	Not the most recent systematic review (for 270-degrees vs. Nissen).
Agrawal S, Shapey I, Peacock A, Ali A, Super P. Prospective study of routine day-case laparoscopic modified Lind partial fundoplication. World J Surg. 2009 Jun;33(6):1229-34. doi: 10.1007/s00268-009-0026-2. PMID: 19363692.	Wrong study design: modified Lind partial fundoplication in all cases, no RCT.
Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Håkanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034. PMID: 35511051; PMCID: PMC9070466.	Wrong study population/intervention: paraoesophageal hernia repair.
Blake KE, Zolin SJ, Tu C, Baier KF, Beffa LR, Alaedeen D, Krpata DM, Prabhu AS, Rosen MJ, Petro CC. Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial. Trials. 2022 Jul 30;23(1):616. doi: 10.1186/s13063-022-06571-8. PMID: 35907909; PMCID: PMC9338471.	Wrong study population/intervention: paraoesophageal hernia repair.
Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021 Jul;35(7):3449-3458. doi: 10.1007/s00464-020-07792-1. Epub 2020 Jul 16. PMID: 32676727; PMCID: PMC8195805.	Wrong study design: observational registry study evaluated, hence no RCT.
Chen Z, Thompson SK, Jamieson GG, Devitt PG, Game PA, Watson DI. Anterior 180-degree partial fundoplication: a 16-year experience with 548 patients. J Am Coll Surg. 2011 May;212(5):827-34. doi: 10.1016/j.jamcollsurg.2010.12.051. Epub 2011 Mar 17. PMID: 21414812.	Interesting as background article however wrong study design: perioperative data and clinical outcomes were determined prospectively using a structured questionnaire. However, because of long term (10 year follow-up), this might be interesting as a background article to determine late clinical outcomes/satisfaction of patients.
Fanous M, Wei W. The Outcomes of Performing Partial Fundoplication Based on Endoflip Versus Manometric Findings. Am Surg. 2022 May;88(5):908-914. doi: 10.1177/00031348211054565. Epub 2021 Nov 18. PMID: 34794325.	Wrong study design: retrospective cohort and wrong study population: hiatal hernia.
Grant AM, Wileman SM, Ramsay CR, Mowat NA, Krukowski ZH, Heading RC, Thursz MR, Campbell MK; REFLUX Trial Group. Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial. BMJ. 2008 Dec 15;337:a2664. doi: 10.1136/bmj.a2664. PMID: 19074946; PMCID: PMC2603580.	Wrong comparison: surgical versus medical.
Hüttl TP, Hohle M, Wichmann MW, Jauch KW, Meyer G. Techniques and results of laparoscopic antireflux surgery in Germany. Surg Endosc. 2005 Dec;19(12):1579-87. doi: 10.1007/s00464-005-0163-0. Epub 2005 Oct 5. PMID: 16211438.	Wrong study design: Not an RCT. This study used a survey to determine outcomes of laparoscopic anti-reflux surgery.
Kappelle WF, Bredenoord AJ, Conchillo JM, Ruurda JP, Bouvy ND, van Berge Henegouwen MI, Chiu PW, Booth M, Hani A, Reddy DN, Bogte A, Smout AJ, Wu JC, Escalona A, Valdovinos MA, Torres-Villalobos G, Siersema PD. Electrical stimulation therapy of the lower oesophageal sphincter for refractory gastro-oesophageal reflux disease - interim results of an international multicentre trial. Aliment Pharmacol Ther. 2015 Sep;42(5):614-25. doi: 10.1111/apt.13306. Epub 2015 Jul 8. PMID: 26153531.	Wrong intervention: intervention is electrical stimulation therapy.
Lal P, Leekha N, Chander J, Dewan R, Ramteke VK. A prospective nonrandomized comparison of laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication in Indian population using detailed objective and subjective criteria. J Minim Access Surg. 2012 Apr;8(2):39-44. doi: 10.4103/0972-9941.95529. PMID: 22623824; PMCID: PMC3353611.	Wrong study design: not randomized.
Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, Perry KA, Birkenhagen WK, Taiganides PA, Dunst CM, McCollister HM, Lipham JC, Khaitan LK, Tsuda ST, Jobe BA, Kothari SN, Gould JC. Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study. Ann Surg. 2019 Aug;270(2):302-308. doi: 10.1097/SLA.0000000000002789. PMID: 29697454.	Wrong intervention: is a device magnetic sphincter augmentation with the LINX.
Messer N, Ben Yehuda A, Idan C, Mimouni I, Warnaar N, Szold A. Anterior reconstruction of the esophageal hiatus: a novel approach for the repair of large diaphragmatic hernias. Minim Invasive Ther Allied Technol. 2023 Aug;32(4):175-182. doi: 10.1080/13645706.2023.2211660. Epub 2023 May 16. PMID: 37191360.	Wrong intervention: large diaphragmatic hernias.
Nwokedi U, Nguyen DT, Meisenbach LM, Chihara R, Chan EY, Graviss EA, Kim MP. Short-term outcome of routine use of EndoFLIP during hiatal hernia repair. Surg Endosc. 2021 Jul;35(7):3840-3849. doi: 10.1007/s00464-020-07788-x. Epub 2020 Jul 14. PMID: 32661713.	Wrong intervention: hiatal hernia repair.
Pessaux P, Arnaud JP, Delattre JF, Meyer C, Baulieux J, Mosnier H. Laparoscopic antireflux surgery: five-year results and beyond in 1340 patients. Arch Surg. 2005 Oct;140(10):946-51. doi: 10.1001/archsurg.140.10.946. PMID: 16230543.	Wrong study design Retrospective study using a survey.
Shapey IM, Agrawal S, Peacock A, Super P. A prospective cross-sectional study of laparoscopic subtotal Lind fundoplication for gastro-oesophageal reflux disease--a durable and effective anti-reflux procedure. Int J Surg. 2015 Jan;13:257-260. doi: 10.1016/j.ijsu.2014.12.013. Epub 2014 Dec 19. PMID: 25529280.	Wrong study design: A prospective cross-sectional study.
Tekin K, Toydemir T, Yerdel MA. Is laparoscopic antireflux surgery safe and effective in obese patients? Surg Endosc. 2012 Jan;26(1):86-95. doi: 10.1007/s00464-011-1832-9. Epub 2011 Aug 24. PMID: 21863377.	Wrong population group and no comparison: patients with different BMI are compared that underwent laparoscopic anti-reflux surgery (LARS). TIAB shows no specific comparison of total versus partial.
Wong HJ, Vierra M, Hedberg M, Attaar M, Su B, Kuchta K, Chiao G, Linn JG, Haggerty SP, Ujiki MB. A Tailored Approach to Laparoscopic Fundoplication: Outcomes in Patients with Esophageal Dysmotility. J Gastrointest Surg. 2022 Dec;26(12):2426-2433. doi: 10.1007/s11605-022-05452-4. Epub 2022 Oct 11. PMID: 36221019.	Wrong study design: A retrospective review of a prospective quality-database.
Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Epub 2014 Aug 19. PMID: 25135443; PMCID: PMC4293474.	Wrong intervention/comparison: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler intervention. The article does not compare with Nissen.
Zehetner J, Holzinger F, Breuhahn T, Geppert C, Klaiber C. Five-year results of laparoscopic Toupet fundoplication as the primary surgical repair in GERD patients: is it durable? Surg Endosc. 2006 Feb;20(2):220-5. doi: 10.1007/s00464-005-0051-7. Epub 2006 Jan 2. PMID: 16391962.	Wrong study design: descriptive and no comparison.
Davis CS, Baldea A, Johns JR, Joehl RJ, Fisichella PM. The evolution and long-term results of laparoscopic antireflux surgery for the treatment of gastroesophageal reflux disease. JSLS. 2010 Jul-Sep;14(3):332-41. doi: 10.4293/108680810X12924466007007. PMID: 21333184; PMCID: PMC3041027.	Wrong study design: included reports as well.
Du HX, Tan GW, Yang ZL, Wang ZG. [Meta-analysis of laparoscopic Nissen and Toupet fundoplication for gastro-oesophageal reflux disease]. Zhonghua Wei Chang Wai Ke Za Zhi. 2012 Aug;15(8):814-8. Chinese. PMID: 22941684.	Wrong language: Chinese.
Elgandashvili D, Kiladze MM. Laparoscopic surgery of hiatal hernia and gastro-esophageal reflux disease. Georgian Med News. 2014 Jun;(231):17-20. PMID: 25020164.	Wrong study population: surgery of hiatal hernia.
Grant AM, Boachie C, Cotton SC, Faria R, Bojke L, Epstein DM, Ramsay CR, Corbacho B, Sculpher M, Krukowski ZH, Heading RC, Campbell MK; REFLUX trial group. Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial). Health Technol Assess. 2013 Jun;17(22):1-167. doi: 10.3310/hta17220. PMID: 23742987; PMCID: PMC4781276.	Wrong comparison: studies are about new technologies (TIF, MSA) and they do not compare partial with total.
Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial)	Wrong comparison: Surgical versus medical.
Hajjar A, Verhoeff K, Jogiat U, Mocanu V, Birch DW, Switzer NJ, Wong C, Karmali S. Endoscopic plication compared to laparoscopic fundoplication in the treatment of gastroesophageal reflux disease: a systematic review and meta-analysis. Surg Endosc. 2023 Aug;37(8):5791-5806. doi: 10.1007/s00464-023-10202-x. Epub 2023 Jul 5. PMID: 37407715.	Wrong comparison: endoscopic plication.
Seo HS, Choi M, Son SY, Kim MG, Han DS, Lee HH. Evidence-Based Practice Guideline for Surgical Treatment of Gastroesophageal Reflux Disease 2018. J Gastric Cancer. 2018 Dec;18(4):313-327. doi: 10.5230/jgc.2018.18.e41. Epub 2018 Dec 27. PMID: 30607295; PMCID: PMC6310769.	Wrong publication type: Guideline.
Slater BJ, Collings A, Dirks R, Gould JC, Qureshi AP, Juza R, Rodríguez-Luna MR, Wunker C, Kohn GP, Kothari S, Carslon E, Worrell S, Abou-Setta AM, Ansari MT, Athanasiadis DI, Daly S, Dimou F, Haskins IN, Hong J, Krishnan K, Lidor A, Litle V, Low D, Petrick A, Soriano IS, Thosani N, Tyberg A, Velanovich V, Vilallonga R, Marks JM. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD). Surg Endosc. 2023 Feb;37(2):781-806. doi: 10.1007/s00464-022-09817-3. Epub 2022 Dec 18. PMID: 36529851.	Wrong publication type: Guideline.
Slater BJ, Dirks RC, McKinley SK, Ansari MT, Kohn GP, Thosani N, Qumseya B, Billmeier S, Daly S, Crawford C, P Ehlers A, Hollands C, Palazzo F, Rodriguez N, Train A, Wassenaar E, Walsh D, Pryor AD, Stefanidis D. SAGES guidelines for the surgical treatment of gastroesophageal reflux (GERD). Surg Endosc. 2021 Sep;35(9):4903-4917. doi: 10.1007/s00464-021-08625-5. Epub 2021 Jul 19. PMID: 34279710.	Wrong intervention/population: both adults and children. Focus is not on partial 180 degrees but just one of the many comparisons.
Tosato F, Marano S, Luongo B, Paltrinieri G, Portale G, Mattacchione S, Bezzi M. Partial or total fundoplication (with or without division of the short gastric vessels): which is the best laparoscopic choice in GERD surgical treatment? Surg Laparosc Endosc Percutan Tech. 2010 Dec;20(6):371-7. doi: 10.1097/SLE.0b013e3181fd6990. PMID: 21150412.	Wrong study design: no SR with RCTs only.
Asti E, Milito P, Froiio C, Milani V, Bonavina L. Comparative outcomes of Toupet fundoplication and magnetic sphincter augmentation. Dis Esophagus. 2023 Jun 15;36(Supplement_1):doac090. doi: 10.1093/dote/doac090. PMID: 36544397.	Wrong study design and wrong comparison: about MSA (compared with Toupet fundoplication. Outcomes GERD HRQL.
Ayav A, Bresler L, Brunaud L, Boissel P. Early results of one-year robotic surgery using the Da Vinci system to perform advanced laparoscopic procedures. J Gastrointest Surg. 2004 Sep-Oct;8(6):720-6. doi: 10.1016/j.gassur.2004.06.002. PMID: 15358334.	Wrong study design and wrong intervention: several robotic surgeries and prospective study
Chew CR, Jamieson GG, Devitt PG, Watson DI. Prospective randomized trial of laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: late outcomes. World J Surg. 2011 Sep;35(9):2038-44. doi: 10.1007/s00268-011-1172-x. PMID: 21713577.	Wrong intervention: only about laparoscopic Nissen fundoplication (anterior versus posterior).
Engström C, Cai W, Irvine T, Devitt PG, Thompson SK, Game PA, Bessell JR, Jamieson GG, Watson DI. Twenty years of experience with laparoscopic antireflux surgery. Br J Surg. 2012 Oct;99(10):1415-21. doi: 10.1002/bjs.8870. PMID: 22961522.	Wrong study design: a standardized questionnaire prospectively for all patients undergoing laparoscopic fundoplication.
Engström C, Ruth M, Lönroth H, Lundell L. Manometric characteristics of the gastroesophageal junction after anterior versus posterior partial fundoplication. Dis Esophagus. 2005;18(1):31-6. doi: 10.1111/j.1442-2050.2005.00445.x. PMID: 15773839.	Wrong comparison: posterior versus anterior partial fundoplication.
Gawron AJ, Bell R, Abu Dayyeh BK, Buckley FP, Chang K, Dunst CM, Edmundowicz SA, Jobe B, Lipham JC, Lister D, Canto MI, Smith MS, Starpoli AA, Triadafilopoulos G, Watson TJ, Wilson E, Pandolfino JE, Kaizer A, Van De Voorde Z, Yadlapati R. Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel. Gastrointest Endosc. 2020 Jul;92(1):78-87.e2. doi: 10.1016/j.gie.2020.01.037. Epub 2020 Jan 31. PMID: 32007519; PMCID: PMC7321870.	Wrong study design: overview of expert opinion and agreements.
Kaindlstorfer A, Koch OO, Antoniou SA, Asche KU, Granderath FA, Pointner R. A randomized trial on endoscopic full-thickness gastroplication versus laparoscopic antireflux surgery in GERD patients without hiatal hernias. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):212-22. doi: 10.1097/SLE.0b013e3182827f79. PMID: 23579521.	Wrong comparison: endoscopic full-thickness gastroplication versus gastroplication.
Loo GH, Rajan R, Deva Tata M, Ritza Kosai N. Changes in the disease-specific quality of life following Dor fundoplication. A multicentre cross-sectional study. Ann Med Surg (Lond). 2020 May 28;55:252-255. doi: 10.1016/j.amsu.2020.05.018. PMID: 32528674; PMCID: PMC7281361.	Wrong study design: A multicenter cross-sectional study.
Mucio M, Rojano M, Herrera JJ, Valdovinos MA, Córdova JÁ, Bravo C, Dominguez L, Sanchez O. Novel surgical concept in antireflux surgery: long-term outcomes comparing 3 different laparoscopic approaches. Surgery. 2012 Jan;151(1):84-93. doi: 10.1016/j.surg.2011.06.024. Epub 2011 Sep 22. PMID: 21943634.	Wrong comparison/intervention: study is about a novel concept in anti-reflux surgery; fixed "nondeformable group was included.
Oor JE, Broeders JA, Roks DJ, Oors JM, Weusten BL, Bredenoord AJ, Hazebroek EJ. Reflux and Belching after Laparoscopic 270 degree Posterior Versus 180 degree Anterior Partial Fundoplication. J Gastrointest Surg. 2018 Nov;22(11):1852-1860. doi: 10.1007/s11605-018-3874-y. Epub 2018 Jul 20. PMID: 30030717.	Wrong comparison: different types of partial fundoplication (LAF) are compared. They are not compared with Nissen.
Radajewski R, Hazebroek EJ, Berry H, Leibman S, Smith GS. Short-term symptom and quality-of-life comparison between laparoscopic Nissen and Toupet fundoplications. Dis Esophagus. 2009;22(1):84-8. doi: 10.1111/j.1442-2050.2008.00887.x. Epub 2008 Nov 12. PMID: 19018854.	Wrong study design: prospective consecutive cohort study.
Rebecchi F, Allaix ME, Cinti L, Nestorović M, Morino M. Comparison of the outcome of laparoscopic procedures for GERD. Updates Surg. 2018 Sep;70(3):315-321. doi: 10.1007/s13304-018-0572-y. Epub 2018 Jul 19. PMID: 30027381.	Wrong study publication: descriptive study of different types and outcomes of laparoscopic procedures for GERD.
Robertson AG, Patel RN, Couper GW, de Beaux AC, Paterson-Brown S, Lamb PJ. Long-term outcomes following laparoscopic anterior and Nissen fundoplication. ANZ J Surg. 2017 Apr;87(4):300-304. doi: 10.1111/ans.13358. Epub 2015 Oct 19. PMID: 26478259.	Wrong study design: prospectively collected database (no RCT).
Shemmeri E, Aye RW. The role of laparoscopic Nissen, Hill, and Nissen-Hill hybrid repairs for uncomplicated gastroesophageal reflux disease. Minerva Chir. 2019 Aug;74(4):320-325. doi: 10.23736/S0026-4733.18.07833-1. Epub 2018 Jul 23. PMID: 30037181.	Wrong study design: description of surgical (laparoscopic) technique.
Watson DI, Jamieson GG, Devitt PG, Kennedy JA, Ellis T, Ackroyd R, Lafullarde T, Game PA. A prospective randomized trial of laparoscopic Nissen fundoplication with anterior vs posterior hiatal repair. Arch Surg. 2001 Jul;136(7):745-51. doi: 10.1001/archsurg.136.7.745. PMID: 11448383.	Wrong intervention: only about laparoscopic Nissen fundoplication (anterior versus posterior).
Wijnhoven BP, Watson DI, Devitt PG, Game PA, Jamieson GG. Laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: long-term results of a randomized trial. Am J Surg. 2008 Jan;195(1):61-5. doi: 10.1016/j.amjsurg.2006.12.046. PMID: 18070731.	Wrong intervention: only about laparoscopic Nissen fundoplication (anterior versus posterior).
Wong AS, Myers JC, Jamieson GG. Esophageal pH profile following laparoscopic total fundoplication compared to anterior fundoplication. J Gastrointest Surg. 2008 Aug;12(8):1341-5. doi: 10.1007/s11605-008-0486-y. Epub 2008 Feb 26. PMID: 18299944.	Wrong focus: aim was to examen the postoperative esophageal acid reflux profiles.
Aiolfi A, Asti E, Bernardi D, Bonitta G, Rausa E, Siboni S, Bonavina L. Early results of magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: Systematic review and meta-analysis. Int J Surg. 2018 Apr;52:82-88. doi: 10.1016/j.ijsu.2018.02.041. Epub 2018 Feb 20. PMID: 29471155.	Wrong comparison: LF (Nissen and Toupet) versus MSA.
Higgins RM, Gould JC. The Pros and Cons of Partial Versus Total Fundoplication for Gastroesophageal Reflux Disease. J Laparoendosc Adv Surg Tech A. 2020 Feb;30(2):117-120. doi: 10.1089/lap.2019.0297. Epub 2019 May 17. PMID: 31100029.	Wrong study design: descriptive study about pro's and con's (not a syst. Review., although RCTs are mentioned).
Hoshino M, Omura N, Yano F, Tsuboi K, Yamamoto SR, Akimoto S, Mitsumori N, Kashiwagi H, Yanaga K. Comparison of laparoscopic Nissen and Toupet fundoplication using a propensity score matching analysis. Surg Today. 2017 Oct;47(10):1195-1200. doi: 10.1007/s00595-017-1490-1. Epub 2017 Mar 1. PMID: 28251373.	Wrong study design: propensity matched scores (hence no RCT).
Joseph SJ, Ebstein AMM, Sapp A. Effectiveness of transoral incisionless fundoplication compared to Toupet fundoplication for chronic or refractory gastroesophageal reflux disease: a systematic review protocol. JBI Database System Rev Implement Rep. 2019 Apr;17(4):507-512. doi: 10.11124/JBISRIR-2017-003893. PMID: 30973524.	Wrong comparison: transoral incisionless fundoplication versus Toupet.
Marshall-Webb M, Peters MDJ, Bright T, Watson DI. Effectiveness of Nissen fundoplication versus anterior and posterior partial fundoplications for treatment of gastro-esophageal reflux disease: a systematic review protocol. JBI Database System Rev Implement Rep. 2018 May;16(5):1095-1102. doi: 10.11124/JBISRIR-2017-003484. PMID: 29762301.	Wrong study design: SR protocol.
Molizzi T. C., Miceli F., Rubino P., Daffinà R., De Maria V., Folino G., Miceli R. A critical review of gastroesophageal reflux surgery. Chirurgia. 2000 jun 13(3):147-50.	Wrong study design: broad review.
Shan CX, Zhang W, Zheng XM, Jiang DZ, Liu S, Qiu M. Evidence-based appraisal in laparoscopic Nissen and Toupet fundoplications for gastroesophageal reflux disease. World J Gastroenterol. 2010 Jun 28;16(24):3063-71. doi: 10.3748/wjg.v16.i24.3063. PMID: 20572311; PMCID: PMC2890948.	Wrong comparison/intervention: study is about a novel concept in anti-reflux surgery; fixed "nondeformable group was included.

180-degrees versus Nissen

Evidence table for systematic review of RCTs and observational studies (intervention studies)

Research question: what are (un)favorable effects of partial (180-degrees anterior or Toupet) fundoplication compared to total or Nissen fundoplication in adults with gastroesophageal reflux disease (GERD)?

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Broeders, 2013

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search up to April 14^th, 2012

A: Baigrie et al., 2005¹

B: Cao et al., 2012

C: Chrysos et al., 2004

D: Raue et al., 2011

E: Watson et al., 1999²

F: Broeders et al., 2011³

G: Ludemann et al., 2005

H: Cai et al., 2008

¹: Baigrie is a combination of A and F. The SR only refers to Baigrie.

²: Watson is a combination of E, G and H. The SR only refers to Watson. G and H are long term follow-up studies.

³: Broeders combined information of Watson (F) and Baigrie (A).

Study design:

A: RCT
B: RCT
C: RCT
D: RCT
E: RCT
F: Follow-up research. Reanalysis of from original data was undertaken to determine outcome at 5 year follow up.
G: Follow-up research ( 5 years after randomization)
H: Follow-up research (10 years after randomization)

Setting and Country:
A: Kingsbury hospital, Cape town, South Africa
B: TianJin NanKai Hospital, NAnKai district, China
C: Unisveristy Hospital of Heraklion, Creta, Greece
D: University Medicine Berlin, Germany

E: Royal Adelaide Hospital, Australia.
F: Hospital in South Africa and hospital in Australia.
G: Royal Adelaide Hospital, Australia.
H. Royal Adelaide Hospital, Australia.

Source of funding and conflicts of interest:

A: No information on Conflict of interest
B: No information on Conflict of interest
C: No information on Conflict of interest
D: The authors declare no conflicts of interest.
E: Authors received grants from the Royal Australasian College of Surgeons Research Foundation and the University of Adelaide’s Faculty of Medicine Research Committee.
F: First author was supported by Utrecht medical Centra and two RCTs conducted in Australia were supported by grants from a medical council.
G: Trials was supported by grants from a medical council of Australia.
H: Trials was supported by grants from a medical council of Australia.

Inclusion criteria SR:

Study population
- Adult patients

- With gastroesophageal reflux disease (GERD)

- Undergoing antireflux surgery, for which intervention should be clearly document: either

180-degrees funduplication (LAF) or 360 degrees fundoplication (LNF).

Study design
Patients should be assigned randomly, and article should be published in a peer-reviewed article.

Exclusion criteria SR:

- If corresponding did not provide data when requested and if it was impossible to abstract data,
- In case only abstracts were available.

Eight publications from five original studies included

Important patient characteristics at baseline:

Number of patients in intervention (% intervention)

A: 79/163, (48%)
control 84/163
B: 50/100, (50%)
control 50/100
C: 12/24, (50%)
control 12/24
D: 32/64, (50%)
control: 32/64
E: 54/107, (50.5%)
control 53/107
F: 121/253, (48%)
control: 132/253
G: 50/101, (49.5%)
control 51/101
H: 41/89, (46%)
control: 48/89

mean age
Ratio intervention/control

A: 45/43
B: 57/59
C: 58/52
D: 53/50
E: 45/47
F: 44.9 [SD: 22-72]/ 44.7 [16-71]
G: NR
H: 58.4/52.9

Sex
Number of males in total (% male in total):

A: 94/163
B: 37/100
C: 13/24
D: 30/64
E: 79/107
F: 154/253
G: 68/101
H: 62/89 (70%)

Groups comparable at baseline?

Cao and Watson et al. also included patients with esophageal dysmotility. These were however divided equally over groups.

No further comments were reported.

Describe intervention:

A-H: 180-degrees fundoplication (LAF)

Describe control:

A-H: Total or Nissen fundoplication (LNF)

End-point of follow-up:

A: 3, 12 and 24 months.

B: 6, 12, 24, 60 months

C: 5 months

D: 10 days, 18 months

E: 1, 3, 6 months

F: 5 years

G: 5 years

H: 10 years

For how many participants were no complete outcome data available?

(intervention/control)

A: Overall loss to follow up: 2 at 12 months
Overall loss to follow up: 1 at 24 months

B: 2/1 at 24 months
1/3 at 60 months.

C: -

D: 2/5

E: 1/0 at 1 month
Overall loss to follow up: 3 at 3 months
Overall loss to follow up: 1 at 6 months
F: 12/5

G: Overall loss to follow up: 4

H: 12/6

Health-related quality of Life

Defined as:

Visick score (patients scoring 1 or 2)^*

Visick score (6 – 18 months) number of events, n (%)
A: I: 73/79 (92%)
    C: 79/83 (96%)
RR 0.97 (95%CI; 0.90 to 1.05)
B: Not reported
D: I: 21/30 (70%)
    C: 25/27 (93%)
RR 0.76 (95%CI; 0.58 to 0.98)
E: I: 43/53 (81%)
    C: 39/53 (74%)
RR 1.10 (95%CI; 0.90 to 1.36)

Visick score (5 years)
number of events, n (%)
B: Not reported

F: I: 96/116 (82.8%)
C: 105/129 (81.4%)

RR 1.02 (95%CI; 0.90 to 1.14)

G: I: 42/50 (84%)
C: 39/51 (76%)
RR 1.10 (95%CI; 0.90 to 1.33)

Visick score (10 years)
number of events, n (%)

H: Not reported

Gastro-reflux disease health related quality of life

Gastro-reflux disease health related quality of life (6 – 18 months)

A: Not reported
B: Not reported
D: I: 109 (range 73 to 122)
C: 110 (range: 84 to 127)
E: Not reported

Gastro-reflux disease health related quality of life (5 years)
B: Not reported

F: Not reported
G: Not reported

Gastro-reflux disease health related quality of life (10 years)

H: Not reported

Dysphagia
Defined as

Dakkak dysphagia score
Mean Dakkak dysphagia (SD) (6 – 18 months)
A: I: 1.0 (95%CI: 0.4 to 1.7)
    C: 3.5 (95%CI; 2.0 to 4.9)
MD -2.50 (95%CI; -4.04 to -0.96)
B: I: 6.4 (SD: 2.3)
    C: 7.8 (SD: 2.9)
MD -1.40 (95%CI; -2.35 to -0.45)
D: Not reported
E: I: 2.1 (95%CI: 0.3 to 3.8)
    C: 4.3 (95%CI: 2.4-5.9)
MD -2.20 (95%CI; -4.48 to 0.08)

Mean Dakkak dysphagia (SD) (5 years)
B: I: 5.3 (SD: 1.1)
C: 7.2 (SD: 2.4)
MD -1.90 (95%CI; -2.63 to -1.17)

F: I: 5.3 (SD: 7.3)

C: 8.8 (SD: 9.5)
MD -3.50 (95%CI; -5.58 to -1.42)

G: I: 6.5 (SD: not mentioned)
C: 11.4 (SD: not mentioned)

Mean Dakkak dysphagia (SD) (10 years)
H: I: 7.8
C: 12.0

Events of dysphagia

Events of dysphagia (6-18 months)
number of events, n (%)

A: I: 1/79 (1.3%)
    C: 4/83 (4.8%)
RR 0.26 (95%CI; 0.03 to 2.30)
B: Not reported
D: I: 3/30(10%)
    C: 2/27(7%)
RR 1.35 (95%CI; 0.24 to 7.48)
E: I: 9/53 (17%)
    C: 22/53 (42%)
RR 0.41 (95%CI; 0.21 to 0.80)

Events of dysphagia (5 years)
number of events, n (%)
B: Not reported
F: I: 8/38 (21.1%)
C: 19/33 (57.6%)
RR 0.20 (95%CI; 0.07 to 0.56)

G*: I: 9/50 (18%)
C: 14/51 (27%)
RR 0.58 (95%CI; 0.22 to 1.50)
*assessment of dysphagia for solids

Events of dysphagia (10 years)
number of events, n (%)
H: I: 14/41(34%)
C: 25/48 (52%)
RR 0.48 (95%CI; 0.20 to 1.13)

Reflux control

DeMeester score

DeMeester score (SD) (6 – 18 months)
A: Not reported
B: I: 13.4 (SD: 4.1)
C: 12.0 (SD: 3.6)
MD: 1.40 (95%CI; -0.11 to 2.91)
D: I: median 12 (range: 2-42)
C: median 10 (range: 2-41)
E: Not reported

DeMeester score (SD) (5 years)
B: I: 10.2 (SD:1.9)

C: 9.5 (SD: 3.2)
MD 0.70 (95%CI; -0.33 to 1.73)

F: Not reported

G: Not reported

DeMeester score (SD) (10-years)
H: Not reported

Proton-pump inhibitor (PPI) use

PPI use (6-18 months), n (%)

A: Not reported
B: Not reported
D: Not reported
E: Not reported

PPI use (5 years), n (%)
B: I: 4/49 (8.2%)
C: 4/47 (8.5%)
RR: 0.96 (95%CI; 0.25 to 3.62)

F: Not reported

G: I: 2/50 (4%)
C: 6/51 (12%)
RR: 0.34 (95%CI; 0.07 to 1.61)

PPI use (10 years), n (%)
H: I: 11/41(27%)
C: 9/48 (19%)
RR: 1.43 (95%CI; 0.66 to 3.11)

Gas Bloating

Events gas bloating (6-18 months)

number of events, n (%)

A: Not reported
B: Not reported
D: I: 2/30 (7%)
C: 3/27(11%)
RR: 0.60 (95%CI; 0.11 to 3.32)
E: I: 10/53 (19%)
C: 15/53 (28%)
RR: 0.67 (95%CI; 0.33 to 1.35)

Events gas bloating (5 years)
number of events, n (%)
B: Not reported

F: I: 63/120 (52.5%)
C: 77/132 (58.3%)
RR 0.90 (95%CI; 0.72 to 1.12)

G: I: 22/50 (44%)
C: 38/51 (75%)*
*upper abdominal bloating
RR 0.59 (95%CI; 0.42 to 0.84)

Events gas bloating (10 years)
number of events, n (%)
H: I: 19/41(46%)
C: 14/48 (29%)
RR 1.59 (95%CI; 0.92 to 2.57)

*epigastric bloating

Flatulence

Flatulence (6-18 months)

number of events, n (%)

A: Not reported
B: Not reported
D: Not reported
E: I: 15/23 (28%)
C: 26 (49%)

Flatulence (5 years)
number of events, n (%)
B: Not reported

F: I: 57/120 (51.8%)
C: 79/119 (66.4%)

G: I: 31/50 (62%)
C: 41/51 (80%)

Flatulence (10 years)
number of events, n (%)
H: Not reported

Risk of bias (high, some concerns or low):

Tool used by authors: Jadad score

A: [High, Some concerns, Low]

Roks (2017)

Study design

12 years follow-up from a

randomized controlled trial (Baigrie 2005)

Setting & country

Kingsbury hospital, Cape town, South Africa

Source of funding and conflicts of interest

This study reported no information on how it was funded.

The authors declared to have no conflict of interest.

Inclusion criteria

- GORD was defined as unequivocal reflux disease

during endoscopy.

- All patients underwent

preoperative endoscopy.

- In patients who did not satisfy

the endoscopic criteria, 24-h pH monitoring and manometry were performed to diagnose GORD objectively.

- All patients had an unequivocal response to proton pump inhibitor therapy.

Exclusion criteria

- Patients who had undergone

antireflux surgery previously.

- Patients younger than 18 years

of age.

Important patient characteristics at baseline:

Number of patients in intervention (% intervention)

38/90 (42%)

Mean age
ratio intervention/control

46/43

Sex
Number of males in total (n, %):

I: 29 (56%)

C: 19 (50%)

180-degrees fundoplication (LAF)

Total or Nissen fundoplication (LNF)

End-point of follow-up:

12 years

For how many participants were no complete outcome data available?

(intervention/control)

Total lost to follow-up (n=73)

- Died (n=4)

- Not traceable (n=55)

- Refused (n=14)

Health-related quality of Life

Visick score (patients scoring 1 or 2)^*

Visick score (10-yeas)

I: 28 (74%)

C: 45 out of 50 (90%)

Gastro-reflux disease health related quality of life (at 10-years)
number of events, n (%)

Not reported

Dysphagia

Dakkak dysphagia score

Mean Dakkak (SD) dysphagia dysphagia (10-years)
I: 2.5 (0 - 37.5) (n=50)

C: 4.0 (0 - 40.0) (n=35)

Events of dysphagia (10-yeas)
number of events/N (%)
Not reported

Reflux control

DeMeester score

Not reported

Proton-pump inhibitor (PPI) use,

PPI use (10 years), n (%)

I: 11 (29%)

C: 4 (8%)

Gas Bloating

Events gas bloating (10-years)
number of events, n (%)
I: 20 (53%)

C: 21 (40%)

Flatulence
Events (increased) flatulence (10-years)
number of events, n (%)
I: 18 (58%)

C: 30 (47%)

Note *Favorable Visick score was reported. This include patients with a Visick score of 1 and 2. Score 3-5 are unfavorable Visick scores and were not reported.

270-degrees versus Nissen

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Li, 2023

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search up to April 14^th, 2012

A: Booth et al., 2008

B: Chrysos et al., 2003

C: Guerin et al., 2007

D: Hakanson et al., 2019

E: Koch et al., 2013

F: Shaw et al., 2010

Strate (2008) and Wang (2015) are not included in our study due to other follow-up periods.

Study design:

A: RCT
B: RCT
C: RCT
D: RCT
E: RCT
F: RCT
G: RCT

Setting and Country:
A: England
B: Greece
C: Belgium
D: Sweden
E: Austria
F: South Africa

Source of funding and conflicts of interest:

A: not mentioned by the authors
B: not mentioned by the authors
C: not mentioned by the authors
D: the study was support by grants from the Stockholm City Council and Erling-Persson Family foundation. Funders had no role in the manuscript analysis, collection and interpretation of manuscript.
E: Authors declare no conflicts of interest or financial ties.
F Only Dr. Metz received grants/consultant fees from Astra Zeneca, Takeda pharmaceuticals, Wyeth, Nycomes and Santarus. Other authors have no conflicts of interest or financial ties.

Inclusion criteria SR:

Study population
- Patients (16 years)

- With symptoms of and diagnosed gastroesophageal reflux disease (GERD), dominated by heartburn and acid regurgitation

- endoscopy-tested esophagitis or patients with 24 hour pathological pH surveillance.

Study design
-RCT with comparison LNF and LTF
-Raw data can be provided on studies.

Exclusion criteria
-Patients with previous gastric/antrifelux/other emajor upper abdominal surgery
-Pregnancy
-non-270 posterior partial fundoplication.

Ten publications from eight original studies were included in the SR. We analyzed 6 original studies.

Important patient characteristics at baseline:

Number of patients in intervention (% intervention)

A: 58/117 (49.6%)
control 59
B: 19/33 (57.6%)
control 14
C: 57/121(47.1%)
control 64
D: 228/455 (50.1%)
control: 227
E: 57/111 (51.4%)
control 54
F: 47/95 (49.5%)
control 48

mean age
Ratio intervention/control

A: 44.2 (19-69)/45.3 (21-86)
B: 59.2 (+11.5)/61.7 (+8.7)
C: Not reported
D: 47.9(+11.7)/50.2(+11.7)
E: 51.87(25-81)/50.32(20-76)
F: 45.6 (25-67)/45.2(28-72)

Sex
Number of males in total (% male intervention/control in total):

A: 43/63 (73%)
41/64 (64%)
B: 11/19 (58%)
7/14 (50%)
C: 32/63 (51%)
54/77 (70%)
D: 134/229 (58.5%)
134/227(59%)
E: 43/63 (68%)
35/62 (56%)
F: 29/50 (58%)
31/50 (62%)

Groups comparable at baseline?

Hakanson (2019, report significant differences of demographic baseline characteristics and preoperative complications. Shaw (2010) used another wrap length (1cm in LNF and 2 cm wrap in LTF)

No further comments were reported.

Describe intervention:

A-H: Laproscopic Toupet fundoplication (LTF)

Describe control:

A-H: Total or Nissen fundoplication (LNF)

End-point of follow-up:

A: 6 and 12

B: 12 months

C: 12 months

D: 12 months, 5 years

E: 12 months

F: 60 months (5 years)

For how many participants were no complete outcome data available?

(intervention/control)

A: 5/5 (at one year)

B: no loss to follow up

C: 6/13

D:
One year follow up
-36 ( out of 229) lost to complete endoscopy / 31 (out of 227) lost to complete endoscopy (at one year)
-39 lost to complete QoL questionnaire / 36 lost to complete QoL questionnaire (at one year)
Five-year follow up
-51 lost to complete QoL questionnaire
-50 lost to complete QoL questionnaire

E: 6/8 (at one year)
F: 12/10 (at longest follow up interval)

Health-related quality of Life

Defined as:

Visick score (patients scoring 1 or 2)^*

Visick score (6 – 18 months) number of events, n (%)
A:I 53/58 (91%)
    C: 54/59 (92%)
RR 1.00 (95%CI 0.90 to 1.12)
B: I: 17/19 (89%)
    C: 13/14 (93%)
RR 1.04 (95%CI; 0.84 to 1.28)
C: I: 56/57 (98%)
    C: 63/64 (98%)
RR 1.00 (95%CI; 0.96 to 1.05)

Visick score (5 years)
number of events, n (%)
F: I: 33/48 (69%)
C: 34/47 (72%)

RR: 1.05 (95%CI: 0.81 to 1.36)

Visick score (10 years)
number of events, n (%)

H: Not reported

Gastro-reflux disease health related quality of life

Not reported

Dysphagia
Defined as

Dakkak dysphagia score
Not reported

Events of dysphagia

Events of dysphagia (6-18 months)
number of events, n (%)

A: I: 5/58 (8.6%)
C: 16/59 (27%)*
RR 3.15 (95%CI; 1.23 to 8.02)
B: I: 3/19 (16%)
C: 2/14 (14%)

RR 0.90 (95%CI; 0.17 to 4.71)
C: I: 4/57(7%)
C: 3/64(4.7%)
RR 0.67 (95%CI; 0.16 to 2.68)
*Only used data at one year follow up time.

Events of dysphagia (5 years)
number of events, n (%)
F: I: 1/48(2%)
C: 3/47(6.4%)
RR 3.06 (95%CI: 0.33 to 28.41)

Events of dysphagia (10 years)
number of events, n (%)
Not reported

Reflux control

DeMeester score

DeMeester score (SD) (6 – 18 months)
A: not reported
B: I: 12 (SD 4)
C: 14 (SD 5)
Mean difference: 2.00 (95%CI -1.19 to 5.18)
C: Not reported
D: Not reported
E: I: 6.94 (SD 13.72)
C: 7.99 (SD 22.3)
Mean difference: 1.05 (-5.88 to 7.98)

DeMeester score (SD) (5 years)
F: I: 10.36 (SD 21.55)
C: 9.84 (SD 24.32)

Mean difference: -0.52 (-10.36 to 9.32)

DeMeester score (SD) (10-years)
not reported

Proton-pump inhibitor (PPI) use

PPI use (6-18 months), n (%)

A: Not reported
B: Not reported
C: Not reported
D: I: 35/228 (15%)
C: 37/227 (16%)
RR: RR 0.95; 95% CI 0.62 to 1.46
E: Not reported

PPI use (5 years), n (%)
F: I: 5/48 (10%)
C: 7/47 (15%)
RR: 1.43 (0.49 to 4.19)

PPI use (10 years), n (%)
Not reported

Gas Bloating

Events gas bloating (6-18 months)

number of events, n (%)

A: I: 6/58 (10%)
    C: 11/59 (19%)*
RR 1.80 (0.71 to 4.55)
B: I: 3/19 (16%)
    C: 3/14 (21%)
RR 1.36 (95%CI 0.32 to 5.75)
C: I: 8/57 (14%)
    C: 12/64 (19%)
RR: 1.34 (95%CI: 0.59 to 3.03)

Total RR: 1.50 (95%CI 0.86 to 2.64)
**Only used data at one year follow up time.

D: Not reported
E: Not reported

Events gas bloating (5 years)
number of events, n (%)
F: Not reported

Events gas bloating (10 years)
number of events, n (%)
Not reported

Flatulence

Not reported

Risk of bias (high, some concerns or low):

Tool used by authors: Cochrane Risk of bias tool

A: Some concerns

B: Some concerns

C: Some concerns

D: No concerns

E: Some concerns

F: No concerns

Paranyak (2023)

Study design

RCT

Setting & country

Ukraine

Source of funding and conflicts of interest

Not reported

Inclusion criteria

- Patients with documented GERD and extraesophageal

refux symptoms

- Diagnosis was

confrmed by clinical evaluation of esophageal and extraeesophageal symptoms, endoscopy,

pH monitoring,

and response to PPI therapy.

Exclusion criteria

- age under 18

years;

- previous anti-reflux surgery, other surgical procedures

in the vicinity of the gastroesophageal junction;

- HH type IV;

major psychiatric illness;

- unstable chronic illnesses

- inability of the patient to complete

the survey.

Important patient characteristics at baseline:

Number of patients in intervention (% intervention)

I: 60 (50%)

C: 60 (50%)

Mean age
ratio intervention/control

I: 54.6 (±10.2)

C: 51.3 (±12.6)

Sex
Number of males in total (n, %):

I: 28 (46.7%)

C: 23 (38.3%)

Laproscopic Toupet fundoplication (LTF)

Total or Nissen fundoplication (LNF)

End-point of follow-up:

6, 12 and 24 months

For how many participants were no complete outcome data available?

(intervention/control)

6: 2 (3.3%)

12: 8 (13.3%)

24: 16 (26.7%)

6: 2 (3.3%)

12: 5 (8.3%)

24: 13 (21.7%)

Health-related quality of Life

Visick score (patients scoring 1 or 2)^*

Visick score (1-year)

Not reported

Gastro-reflux disease health related quality of life (at 1-year)
number of events, n (%)

Not reported

Dysphagia

Dakkak dysphagia score

Mean Dakkak (SD) dysphagia dysphagia (1-year)
Not reported

Events of dysphagia (1-year)
number of events/N (%)
Not reported

Reflux control

DeMeester score

Not reported (only at baseline)

Proton-pump inhibitor (PPI) use *

PPI use (1 year), n (%)

I: 10 (22.7%)*

C: 8 (17.0%)*

RR 1.25 (95%CI: 0.53 to 2.95)

Not indicated when this was evaluated

Gas Bloating

Events gas bloating (1-year)
number of events, n (%)
Not reported

Flatulence
Events (increased) flatulence (1-year)
number of events, n (%)
Not reported

Table of quality assessment for systematic reviews of RCTs and observational studies

Study First author, year	Appropriate and clearly focused question? Yes/no/unclear	Comprehensive and systematic literature search? Yes/no/unclear	Description of included and excluded studies? Yes/no/unclear	Description of relevant characteristics of included studies? Yes/no/unclear	Appropriate adjustment for potential confounders in observational studies? Yes/no/unclear/not applicable	Assessment of scientific quality of included studies? Yes/no/unclear	Enough similarities between studies to make combining them reasonable? Yes/no/unclear	Potential risk of publication bias taken into account? Yes/no/unclear	Potential conflicts of interest reported? Yes/no/unclear
180-degrees (LAF) vs. total fundoplication (LNF)
Broeders, 2012	Yes	Yes, comprehensive search strategy reported in the paper.	Yes, clear description and flowchart of the included and excluded studies.	Yes	No, not reported, although this was taken account in the individual studies.	Yes, for all articles both the Cochrane Collaboration’s tool for assessing risk of bias and the Jadad scoring system was used.	Yes, a meta-analysis was performed.	Yes, a funnel plot was performed (and did not demonstrate evidence of publication bias).	No, source of funding/support not reported.
270-degrees (LTF) vs. total fundoplication (LNF)
Li, 2023	Yes	Yes, comprehensive search strategy reported in the paper	Yes, a PRISMA flowchart was provided on the included and excluded studies	Yes, the characteristics relevant to PICO were reported in the Evidence Table. Although ratio male/female was not reported in the evidence table. Furthermore,	NA (no observational studies were included).	Yes, for all articles a Cochrane Collaboration’s tool for assessing risk of bias was used.	Yes, meta-analysis was performed.	Yes, a funnel plot was performed (and did not demonstrate evidence of publication bias).	Yes, the author(s) declared no financial support for the research was received.

Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)
Research question: what are (un)favorable effects of partial (180-degrees anterior or Toupet) fundoplication compared to total or Nissen fundoplication in adults with gastroesophageal reflux disease (GERD)?

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Paranyak, 2023

Definitely yes

Reason: a computer-generated block-randomization method was used to

assign patients to the study or the control group. The process

of randomization was performed after the administration of

general anaesthesia with a member of surgical team opening a sealed envelope that specified the group allocation.

Definitely yes

Reason: computer-generated block-randomization method.

Probably yes

Reason: patients remained blinded to their treatment during the following 24 months after surgery. (not reported whether data collectors and analysts were blinded).

Probably yes

Reason: loss

of 20% of patients at 24-month follow-up.

Definitely yes

Reason: all relevant outcomes were reported.

Probably no

Reason: with regard to self-reported questionnaires, recall bias might exist.

Some concerns

Roks, 2017

Definitely yes

Reason: randomization took place using sealed envelopes.

Probably yes

Reason: sealed envelopes were used. Although it was described very brief.

Probably yes

Reason: patients

were interviewed in the years following surgery by an independent investigator, who remained unaware of the operation each patient had undergone. The final analysis of

these double-blinded data was performed jointly by the surgeon and the investigator.

Probably yes

Reason: substantial loss to follow-up (n=73).

Although characteristics

of patients lost to follow-up were similar to those of

patients who completed follow-up.

Definitely yes

Reason: all relevant outcomes were reported.

Probably no

Reason: with regard to self-reported questionnaires, recall bias might exist.

Some concerns

Verantwoording

Autorisatiedatum en geldigheid

Laatst beoordeeld : 14-10-2024

Laatst geautoriseerd : 14-10-2024

Geplande herbeoordeling : 14-10-2026

Initiatief en autorisatie

Initiatief:

Nederlandse Vereniging van Maag-Darm-Leverartsen

Geautoriseerd door:

Nederlands Huisartsen Genootschap
Nederlandse Internisten Vereniging
Nederlandse Vereniging van Maag-Darm-Leverartsen
Nederlandse Vereniging voor Heelkunde
Patiëntenfederatie Nederland

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Kwaliteitsgelden Medisch Specialisten (SKMS). Patiëntenparticipatie bij deze richtlijn werd medegefinancierd uit de Kwaliteitsgelden Patiënten Consumenten (SKPC) binnen het programma KIDZ.

De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2021 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met GORZ.

Werkgroep

Prof. dr. A.J. Bredenoord, MDL-arts, Amsterdam UMC, NVMDL (voorzitter)
Dr. J.M. Conchillo, MDL-arts, Maastricht UMC+, NVMDL
Dr. R.C.H. Scheffer, MDL-arts, Jeroen Bosch Ziekenhuis, NVMDL
Prof. dr. B.L.A.M. Weusten, MDL-arts, UMC Utrecht en Sint Antonius Ziekenhuis Nieuwegein, NVMDL
Dr. V.B. Nieuwenhuijs, Chirurg, Isala, NVvH
Dr. W.E. Hueting, Chirurg, Alrijne Ziekenhuis, NVvH
Prof. dr. M.E. Numans, hoogleraar huisartsengeneeskunde/huisarts, Leiden Universitair Medisch Centrum, NHG
I. van Ee, Adviseur patientenbelang, Patientenfederatie Nederland

Klankbordgroep

M. Claassen, diëtist, Baseline Diëtisten, NVD
Dr. J.W.K. van den Berg, longarts, Isala, NVALT
Drs. R.N.P.M. Rinkel, KNO-arts, Amsterdam UMC, NVKNO
Drs. A. Horikx, apotheker, KNMP
Drs. A. van der Beek, Internist, Ziekenhuis Rivierenland, NIV
Drs. I.B.Y. Tack, arts VG, Erasmus MC, NVAVG
A.M.M. Botter – Mulder MSc, apotheker, Brocacef Ziekenhuisfarmacie, NVAVG

Met ondersteuning van

H. Olthuis-van Essen MSc, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
Dr. N. Kampstra, adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

Werkgroep

Werkgroeplid	Functie	Nevenfuncties	Gemelde belangen	Ondernomen actie
Prof. dr. A.J. Bredenoord (voorzitter)	MDL-arts, Amsterdam UMC	Lid Medische Ethische Toetsing Commissie AMC (onbetaald), Voorzitter Europese EoE research Network EUREOS (onbetaald), Lid Raad van Toezicht MLDS (onbetaald)	Onderwijsvergoedingen door Laborie en Medtronic, Organisator diverse symposia welke deels gesponsord werden door commerciële partijen; PI van onderzoek EoE, financier Nutricia; PI van onderzoek medicatie nuldelijn, financier Bayer en Norgine (afgerond bij start richtlijn, niet behandeld in richtlijn); betrokken bij onderzoek experimenteel behandelapparaat, financier SST (niet behandeld in richtlijn).	Geen restricties
Dr. J.M. Conchillo	MDL-arts, Maastricht UMC+	Secretaris sectie Neurogastroenterologie en Motiliteit NVGE (onbetaald)	Geen	Geen restricties
Dr. R.C.H. Scheffer	MDL-arts, Jeroen Bosch Ziekenhuis	Geen	Geen	Geen restricties
Prof. dr. B.L.A.M. Weusten	MDL-arts, UMC Utrecht	Geen	Allen buiten de scope van de richtlijn: Consultancy Pentax Medical en financiering voor onderzoek over cryoballonablatie (in het kader van Barrett-slokdarm en behandeling diabetes), PI van onderzoek naar cryonballonablatie in Barrett-slokdarm; PI van dosefinding onderzoek voor cryoablatieballon, financier C2-therapeutics en Pentax MEdical; PI van (dierexperimenteel) onderzoek naar nieuwe vorm van ablatie bij Barrett-slokdarm.	Geen restricties
Dr. V.B. Nieuwenhuijs	Chirurg, Isala	Geen	Geen	Geen restricties
Dr. W.E. Hueting	Chirurg, Alrijne Ziekenhuis	Voorzitter netwerk Zuur chirurgen antireflux en hiatale hernia, invited speaker B/D	Geen	Geen restricties
Prof. dr. M.E. Numans	hoogleraar huisartsengeneeskunde LUMC	Huisarts in Utrecht (betaald); Richtlijnontwikkeling NHG: maagklachten, leveraandoeningen	Project leefstijlinterventies bij refluxklachten, geen projectleider, financier: MLDS	Geen restricties
I. van Ee	Adviseur patiëntenbelang, Patientenfederatie Nederland	Patiëntvertegenwoordiger EUPATI-fellow, Coördinator patiëntenparticipatie en onderzoek en lid central redactie bij Psoriasis patiënten Nederland (onbetaald).	Geen	Geen restricties

Klankbordgroep

Klankbord-groep lid	Functie	Nevenfuncties	Gemelde belangen	Ondernomen actie
M. Claassen	Diëtist, Baseline Diëtisten	Geen	Geen	Geen restricties
Dr. J.W.K. van den Berg	Longarts, Isala	Geen	Chronische hoest studies, projectleider, financiële ondersteuning door MSD	Geen restricties
Drs. R.N.P.M. Rinkel	KNO-arts, Amsterdam UMC	Lid Beroepsgenoot Tuchtcollege; Raad van Advies Fontys Hogeschool Logopedie	Geen	Geen restricties
Drs. A. Horikx	Apotheker KNMP	Geen	Geen	Geen restricties
Drs. A. van der Beek	Internist, Ziekenhuis Rivierenland	voorzitter adviescommissie GE NIV (onbetaald)	Geen	Geen restricties
Drs. I.B.Y. Tack	Arts VG voor dokter Tack, Docent Erasmus MC	Consulent CCe (betaald); gastdocent huisartsenopleiding/GZ Psychologen/LACCS (betaald); commissie onderwijs NVAVG (onbetaald)	Geen	Geen restricties
A.M.M. Botter – Mulder MSc	Apotheker, Brocacef Ziekenhuisfarmacie	Geen	Geen	Geen restricties

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door afvaardiging van de Patientenfederatie Nederland in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen (zie kopje waarden en voorkeuren van patiënten). De conceptrichtlijn is tevens voor commentaar voorgelegd aan de Patientenfederatie Nederland en de aangeleverde commentaren zijn bekeken en verwerkt .

Wkkgz & Kwalitatieve raming van mogelijke substantiële financiële gevolgen

Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz

Bij de richtlijn is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling zijn richtlijnmodules op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).

Uit de kwalitatieve raming blijkt dat er waarschijnlijk geen substantiële financiële gevolgen zijn, zie onderstaande tabel.

Module	Uitkomst raming	Toelichting
Antirefluxchirurgie - Technieken	Geen substantiële financiële gevolgen	Uit de toetsing volgt dat de aanbeveling niet breed toepasbaar is (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven.

Methode ontwikkeling

Evidence based

Werkwijze

Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met GORZ. Tevens zijn er (aanvullende) knelpunten aangedragen door de Nederlandse Vereniging van Maag-Darm-Leverartsen, Nederlandse Internisten Vereniging, Nederlandse Vereniging voor Klinische Geriatrie, Nederlands Huisartsen Genootschap, Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie, Nederlandse Vereniging van ZiekenhuisApothekers, Zorginstituut Nederland, Nederlandse Vereniging van Diëtisten, Verpleegkundigen & Verzorgenden Nederland, Nederlandse Vereniging Artsen Verstandelijk Gehandicapten, Nederlandse Vereniging voor Gynaecologie en Obstetrie, Nederlandse Vereniging voor Pathologie, Vereniging Innovatieve Geneesmiddelen en de Nederlandse Vereniging van Ziekenhuizen via een schriftelijke knelpuntenanalyse. Een verslag hiervan is opgenomen onder aanverwante producten. Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.

Uitkomstmaten

Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.

Methode literatuursamenvatting

Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. Indien mogelijk werd de data uit verschillende studies gepoold in een random-effects model. Review Manager 5.4 werd gebruikt voor de statistische analyses. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.

Beoordelen van de kracht van het wetenschappelijke bewijs

De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).

GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).

GRADE	Definitie
Hoog	er is hoge zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt; het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.
Redelijk	er is redelijke zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt; het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.
Laag	er is lage zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt; er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.
Zeer laag	er is zeer lage zekerheid dat het ware effect van behandeling dichtbij het geschatte effect van behandeling ligt; de literatuurconclusie is zeer onzeker.

Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).

Overwegingen (van bewijs naar aanbeveling)

Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE methodiek.

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

	Sterke aanbeveling	Zwakke (conditionele) aanbeveling
Voor patiënten	De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.	Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet.
Voor behandelaars	De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.	Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.
Voor beleidsmakers	De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.	Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen.

Organisatie van zorg

In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen. Meer algemene, overkoepelende, of bijkomende aspecten van de organisatie van zorg worden behandeld in de module Organisatie van zorg.

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd (pending).

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.

Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwaliteit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

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