Study type

Characteristics

Intervention (I)

Controls (C)

Outcome measures and follow-up time

Results

Quality

assessment study

Boccasanta 2011

Design

RCT

N = 100

Country

Italie

Aim of the study:

To compare the clinical and functional outcomes of the

stapled transanal rectal resection, using the traditional 2 circular staplers and a new, curved stapler device in

patients with obstructed defecation caused by rectal intussusception and rectocele.

Inclusion criteria

• IRP (second or third degree (Pescatori’s grading)), or

rectal intussusception

• Rectocele >3cm

• ODS score >15

• Continence score <3

• Resting pressure >40 mm Hg, squeeze pressure >100

mm Hg

Exclusion criteria:

• Previous surgery for rectal prolapse and/or rectocele

• IRP first degree (Pescatori’s grading)

• Rectocele _3 cm

• ODS score _15

• Continence score _3

• Resting pressure _40 mm Hg, squeeze pressure _100

mm Hg

• Concomitant enterocele, compressing the rectum during

evacuation efforts

• Concomitant cystocele, or genital prolapse

• Psychiatric diseases

• Absolute contraindications to surgery.

Intervention

stapled transanal rectal resection with a new, curved multifire stapler

(TRANSTAR group).

N = 50

Controls

stapled transanal rectal resection with

2 traditional circular staplers (STARR group)

N = 50

Primary outcomes:

rate of failure (residual mucosal rectal prolapse,

with an ODS score >5)

Secundary outcomes:

operative time and blood loss,

complications, hospital stay, postoperative pain, time to return to normal

activity, outcome of surgery on the ODS score, quality of

life on the SF36 Health Survey questionnaire, costs, and

patient satisfaction score.

Follow up:

STARR: 36.3 ± 4.4 months

TRANSTAR: 36.2 ± 4.2

Primary outcomes:

50 (mean age, 54.8 y; range, 27–77) underwent a conventional STARR with 2

PPH-01 staplers (STARR group) and 50 (mean age, 57.1 y; range, 31–74) had the same operation but with the new stapler CCS-30 (TRANSTAR group).

Six patients from the STARR group (12.0%) and none with TRANSTAR had a prolapse recurrence at clinical examination, with an ODS score <5 (P = .035).

Clearly defined groups:

Selection bias:

Method of assessing the outcome

appropriately:

Selective loss to follow up:

No loss to follow up

Identification confounders and correction in analysis:

Funding:

No financial disclosure

Cadeddu 2012

Design

meta-analysis

N = 8 studies (467 patients)

Aim of the study:

to evaluate long-term results of open and

laparoscopic abdominal procedures to treat full-thickness rectal prolapse in adults.

Inclusion criteria

- articles published between 1972 and 2010 on abdominal rectopexy patients with a follow-up longer than 16 months

Exclusion criteria:

Intervention

Open procedure

N = 275

Controls

Laparoscopic procedure

N = 192

Primary outcomes:

recurrence of rectal prolapse

Secundary outcomes:

improvement in incontinence and constipation

Follow up:

16-59 months

Primary outcomes:

Forest plot A: recurrence; plot B: incontinence; plot C: constipation

Clearly defined groups:

Yes

Selection bias:

No

Method of assessing the outcome

appropriately:

A literature review was performed using the

National Library of Medicine’s PubMed database. All articles published between 1972 and 2010 on abdominal rectopexy patients with a follow-up longer than 16 months were considered.

In the meta-analysis, both randomized and non-randomized trials comparing open and laparoscopic rectopexy with a follow-up longer than 16 months were included. Any technique

for abdominal repair of rectal prolapse was considered, i.e. resection and rectopexy with either suture or mesh.

Selective loss to follow up:

Not applicable

Identification confounders and correction in analysis:

No

Funding:

Not reported

De Hoog 2009

Design

case–control study

N = 82

Country

Netherlands

Aim of the study:

to evaluate recurrence and functional outcome of three surgical techniques for rectopexy: open (OR), laparoscopic (LR), and robot-assisted (RR).

Inclusion criteria

- patients who

underwent a rectopexy for full thickness rectal prolapse between January 2000 and September

2006

- Patients with a “hostile abdomen” after extensive abdominal surgery were deemed eligible for an OR only.

Exclusion criteria:

- age under 18 or patient unfit for surgery.

Intervention

Laparoscopic rectopexy

N = 15

Robot-assisted rectopexy

N = 20

Controls

Open rectopexy

N = 47

Primary outcomes:

recurrence

Secundary outcomes:

Functional results

Follow up:

Median 1.95 years (mean

2.6; range 0.2–8.0).

Primary outcomes:

A total of 82 patients (71 females, 87%) with a mean age of 56.4 years (range, 21–88) were included and underwent an OR (n=47, 57%), LR (n=15, 18%), or RR (n=20, 24%) for rectal procidentia. Forty-one (50%) patients had fecal incontinence (including grade 4 incontinence in 35 patients). Other complaints were

constipation (n=29, 35%).

Nine (11%) of the 82 patients developed a recurrence. Recurrences (Table 1) were more frequent after both minimal invasive rectopexy types compared to open

surgery (respectively LR 27% and RR 20% versus OR 2%; p=0.008). Recurrence occurs significantly more often in younger patients in childbearing age (p=0.003), especially below the age of 40 (50% vs. 6% above the age of 60; p=0.002). Males are more likely to get a recurrence (p=0.013), and fixation of the vaginatop (in patient with previous hysterectomy) protects against recurrence (p= 0.009).

No differences were found for either decrease in Wexner score or IDL score between the three operation types

Fecal incontinence was still present in 27 patients (33%). In 15 of the 42 (36%) patients the fecal incontinence improved after rectopexy.

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

Peri-operative data were collected from patient records and functional outcome was assessed by telephonic questionnaire.

 In the first 42 patients, a Well’s procedure was performed. After rectal mobilization a posterior mesh rectopexy was performed (first described by Wells in 1959). Since

July 2004, the general policy in our department shifted from a modified Well’s procedure towards a D’Hoore ventral mesh rectopexy. In RR, we used the four-armed DaVinci® surgical system (Intuitive Surgical Inc., CA,

USA).

The standardized Wexner constipation score was used to investigate the level of constipation before and after the operation. The Parks–Browning classification was used to grade fecal incontinence

Selective loss to follow up:

Seventy-two (90%) patients answered the

questionnaire (M–F=10:62). Reasons for not taking part were: inaccessibility (four),  psychological illness (three), and unwilling (one). Two patients died during follow-up as a result of non-related causes.

Identification confounders and correction in analysis:

No

Funding:

Not reported

Fleming 2012

Design

Cohort study

N = 1275

Country

USA

Aim of the study:

This study compares 30-day outcomes following

rectal prolapse repair, examining potential surgical and

patient factors associated with perioperative complications.

Inclusion criteria

- The NSQIP database was examined for patients with a primary postoperative diagnosis of rectal prolapse based on the ICD-9 codes

Exclusion criteria:

Intervention

Surgical approach: Abdominal group

(resection compared with rectopexy

alone)

N = 569

Controls

Surgical approach: Perineal group

N = 706

Primary outcomes:

morbidity

Secundary outcomes:

Follow up:

30-day postoperative

Primary outcomes:

There were 153 major complications recorded in the 30-day postoperative period,

involving 94 (7.4%) patients, and 86 minor complications in 85 (6.7%) patients.

After adjustment, a perineal approach was associated with a lower postoperative complication rate of both major (perineal vs abdominal: OR, 0.46; 95% CI, 0.31–0.80; P = 0.0038) and minor complications (perineal vs abdominal: OR, 0.35; 95% CI, 0.20–0.60; P = 0.0002).

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) comprises a clinical database with systematic data collection from hundreds of hospitals throughout the United States. the programme collects

information pertaining to patient demographics, preoperative medical history, clinical findings and laboratory investigations. After discharge, follow-up data are obtained from chart review and a standardized phone interview by a certified nurse reviewer. The NSQIP database was examined for patients with a primary postoperative diagnosis of rectal prolapse (569.1) based on the International Classification of Disease, 9^th Edition (ICD codes). The primary diagnosis category was then cross-referenced with the Current Procedural

Terminology (CPT) codes to select for cases that

specifically coded for a rectal prolapse procedure. Major complications included organ space (peritoneal) infections, cardiac events, ventilator

dependence (re-intubation or failure to wean), pneumonia, venous thromboembolic events, return to the operating room (OR), renal failure, and sepsis. NSQIP uses the Center for Disease Control (CDC) definitions for septic end-points. Minor complications included surgical site infections (superficial to the fascia) and urinary

tract infections.

Selective loss to follow up:

No

Identification confounders and correction in analysis:

Yes, operative approach, preoperative steroid use, pulmonary comorbidity, cardiac comorbidity, ASA class, functional status and preoperative platelet count

Funding:

Not reported

Isbert 2010

Design

Cohort study

N = 150

Country

Germany

Aim of the study:

to compare the morbidity

and functional results at 12-month follow-up in patients undergoing either two circular stapling devices (PPH)-STARR or Contour Transtar (CT) for obstructive

defecation syndrome (ODS).

Inclusion criteria

- women with defecatory disorders who underwent a STARR from January 2006 until May 2008

Exclusion criteria:

Intervention

PPH-STARR

N = 68

Controls

CT-STARR

N = 82

Primary outcomes:

Secundary outcomes:

Follow up:

12-month

postoperatively

Primary outcomes:

Four (10%) patients following PPH-STARR and four (10.5%) patients following CT group suffered persistent obstructive defecation or pain. Five patients (10.5%) in the PPH-STARR group and two (8.3%) in the CT group complained about new onset

incontinence for flatus. There was no significant difference between the

preoperative and 12-month follow-up incontinence scores for either group.

Clearly defined groups:

Yes. Initially, the conventional double stapling technique, using two PPH01 devices, was used to perform STARR. At the beginning of 2007 the CT device was used in addition. In the latter cases, the decision about whether to perform CT or PPH-STARR was made on the basis of the diameter of anal canal and the size of the rectal prolapse as assessed at operation (<3 cm after gentle dilatation); patients with larger prolapse were preferentially selected for CT.

Selection bias:

Yes, see ‘clearly defined groups’

Method of assessing the outcome

appropriately:

Yes, 12 months postoperatively patients were referred for examination that included symptom evaluation, using the same standardized questionnaires for constipation and incontinence, clinical examination and investigation using

video-rectoscopy and anal manometry.

Selective loss to follow up:

Forty of the 68 (58%) patients in the PPH-STARR group and 38 of the 82 (46%) patients in the CT group attended for follow-up assessment at 12-month follow-up.

Identification confounders and correction in analysis:

No

Funding:

Not reported

Johnson 2012

Design

Cohort study

N = 48

Country

Norway

Aim of the study:

To study the short- and long-term outcome of resection rectopexy in patients with internal rectal intussusception (IRI)

Inclusion criteria

- patients with IRI who had resection

rectopexy between February 1999 and June 2006.

Exclusion criteria:

Intervention

resection rectopexy

N = 48

Controls

No

Primary outcomes:

morbidity, scores for constipation (KESS score) and anal incontinence, patients’ report, and health-related

quality of life (HRQoL)

Secundary outcomes:

Follow up:

76 months (57-129)

Primary outcomes:

Rectopexy with suture and sigmoid resection was performed. The operation was

done laparoscopically in 25 patients and by open access in 23 patients, including conversions to open operation in three patients.

Morbidity. Eight patients (16.7%) had major early morbidity. In open surgery, four patients had partial transection of ureter, reoperations for bleeding, or percutaneously drained intra-abdominal abscess. In laparoscopic surgery,

four patients had rectal perforation necessitating temporary ostomy, incarcerated hernia, hematoma fromtrocar-induced lesion of inferior epigastric artery, or lung embolus. Three patients (6.3%) had delayed morbidity with operations for

incisional hernia, intestinal obstruction, and anastomotic stricture including a temporary ostomy. Four patients (8.3%) had additional surgery in order to

improve outcome, of whom three had operations for proctocele and transanal stapled resection ofmucosal prolapse (n = 2). One patient with a persisting enterocele had at defecation pain and incomplete evacuation of stool, that was relieved by stretching close to supine position. She underwent a laparoscopic suture of anterior rectum to anterior pelvic peritoneum that removed the enterocele and relieved her symptoms. A fifth patient improved from increased constipation

after resection rectopexy, by sacral nerve stimulation.

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

The patients were examined in the outpatient

clinic preoperatively and at short-term followup (Table 1), mainly by two consultants involved in their treatment. At long-term followup the patients were evaluated by phone interview by an unfamiliar trainee.

Selective loss to follow up:

Not included in analysis (1 died, 3 didn’t respond)

Identification confounders and correction in analysis:

No

Funding:

No conflict of interests.

Karas 2011

Design

Multicentre RCT

N = 252

Country

21 countries

Aim of the study:

to test the hypothesis that recurrence rates following no rectopexy

are not inferior to those following rectopexy for fullthickness rectal prolapse (FTRP)

Inclusion criteria

All patients older than 18 years presenting at the participating

centers with FTRP were candidates for inclusion in the study provided that they were medically cleared for general anesthesia and that they signed an informed consent.

Exclusion criteria:

1) failure to sign informed

consent; 2) no prior surgery for rectal prolapse; 3) no medical

clearance to undergo general anesthesia (these patients

were considered for perineal surgery under regional anesthesia);

and 4) concomitant pelvic floor descent.

Intervention

abdominal surgery with rectal mobilization only

N = 116

Controls

abdominal surgery with

mobilization and rectopexy.

N = 136

Primary outcomes:

recurrence

rates

Secundary outcomes:

Follow up:

Primary outcomes:

Clearly defined groups:

Yes, In the rectopexy study arm, rectopexy was performed using either a mesh or sutures. Sigmoid resection was added in the case of preexisting documented constipation.

Selection bias:

No

Method of assessing the outcome

appropriately:

Constipation was defined as a Cleveland Clinic Florida score >15, whereas a

score ≤15 was considered normal.11

Selective loss to follow up:

10.3% patients were lost to 5-year follow-up

Identification confounders and correction in analysis:

No

Funding:

This work was supported by research grants from the Western Norway Regional Health Authority, Bergen, Norway; Forde Health System, Forde, Norway; and Ethicon Endo-Surgery, Cincinnati,OH.

Leal 2010

Design

Cohort study

N = 35

Country

Brazil

Aim of the study:

to make a

preoperative and postoperative clinical and functional

evaluation of patients who underwent transanal repair of

rectocele and rectal mucosectomy with a single circular

stapler (TRREMS procedure) as treatment for obstructed

defecation syndrome (ODS) caused by rectocele and rectal

mucosal prolapse (RMP).

Inclusion criteria

- female attending the outpatient coloproctology service at Hospital Getu´lio Vargas (Teresina, Brazil) between March 2006 and April 2008.

- patients were clinically diagnosed with ODS caused by rectocele grade II  or grade III

associated with

anoscopically confirmed RMP with indications for surgery as all of them had been clinically managed (high

fiber diet/laxatives) for a period of at least 4 months.

Exclusion criteria:

- Patients with anismus at cinedefecography (no relaxation of the puborectal muscle during evacuation) and other compartment

prolapses or fecal incontinence (score[10,0)

Intervention

rectal mucosectomy with a single circular

stapler (TRREMS procedure)

N = 35

Controls

No

Primary outcomes:

ODS score, Cleveland Clinic constipation score, functional continence index

Secundary outcomes:

Follow up:

18 ± 7.5 months (range 10–36 months).

Primary outcomes:

This prospective and analytical study included 35 female patients aged 47.5 ± 10.83 years (range 31–67 years).

The average duration of surgery was 45 ± 8.77 min (range 33–70 min). All patients were hospitalized for 24 h with no early complications. Five patients (14.28%) experienced late postoperative complications, including three cases (8.57%) of moderate stenosis observed at 1-month followup, two of which (5.72%) resolved spontaneously (the third patient developed annular stenosis of the mucosa and was

submitted to stricturotomy). One year after surgery, one patient developed a 3.0-cm granuloma on the suture line, which was resected without complications. Another patient experienced intense pelvic pain, proctalgia, hypogastralgia, sensation of pelvic heaviness and dyspareunia. CT and MRI scans revealed thickening of the anterior rectouterine pouch due to endometriosis.

The average ODS score decreased from 10.63 (range 7–17) to 2.91 (range 1–6) (p = 0.001). The average functional continence score fell from 2.77 to 1.71 (p = 0.001), and the average validated Wexner constipation score decreased from 15.23 (range 8–23) to 4.46 (range 1–12) (p = 0.001) after surgery.

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

Yes

Selective loss to follow up:

Not reported

Identification confounders and correction in analysis:

No

Funding:

Not reported

Lehur 2008

Design

RCT

N = 119

Country

France, Italy and UK

Aim of the study:

to assess the safety and

outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients.

Inclusion criteria

- women patients, aged 18 years or older,

diagnosed with ODS associated with rectal intussusception

and/or rectocele and candidates for surgical treatment

- A minimal ODS score of 7 on structured interviewerled

Questionnaires

- An adequate external sphincter function on

rectal examination and evidence of anterior rectocele and/

or rectal intussusception on dynamic defecography

Exclusion criteria:

- clinically evident external sphincter injury, fecal incontinence,

enterocele requiring surgery and anterior defect, colpocele, or cystocele requiring a combined surgical

approach.

Intervention

STARR

N = 59

Controls

three-month electromyographic-based BF training

N = 60

Primary outcomes:

ODS score, PAC-QOL, continence gradeing scale

Secundary outcomes:

Follow up:

12 months

Primary outcomes:

Among the EP, the mean age (±SD) for STARR patients was 56 (±9.2; range, 34–80) years and for BF patients was 56 (±14.3; range, 24–78) years.

Patients assigned to the BF group withdrew at a higher rate than the STARR group (30 (50 percent) vs. 8 (14 percent)), principally the result of high dropout rates at two centers with high enrollment. Sixteen of the 22 BF-treated patients who withdrew cited unsatisfactory results of the procedure. Three STARR and 6 BF patients

were lost to follow-up and one STARR patient withdrew as a result of incontinence that needed further investigation and therapy.

Safety: Adverse events, a secondary end point in the trial, were experienced by eight (15 percent) STARR patients compared with one (2 percent) BF patient who suffered from anal pain during training sessions. Adverse events included local infection, anorectal pain, incontinence, bleeding, urinary infection, or depression. Two patients who underwent the STARR procedure experienced a serious adverse event, one of which, 12-hour postoperative bleeding, was managed under general anesthesia with additional sutures at the site of hemorrhage. The second event, pain in the right upper abdominal quadrant several weeks after surgery, was considered serious because it required hospital care but was not considered to be related to the study device or study procedure.

Clearly defined groups:

Yes

Selection bias:

No

Method of assessing the outcome

appropriately:

Yes

Selective loss to follow up:

Identification confounders and correction in analysis:

No

Funding:

Supported by grants from Ethicon Endo-Surgery (Europe) GmbH, Norderstedt, Germany.

Renzi 2012

Design

RCT

N = 63

Country

Italy

Aim of the study:

to compare the effectiveness and safety of the STARR with 2 circular staplers or with the contour-curved stapler in the treatment of ODS caused by rectocele or

rectal intussusception.

Inclusion criteria

- All patients with ODS who were candidates for STARR at the Colorectal Surgery Unit of S. Stefano Hospital from November 2005 through September 2007

- ODS score≥12; rectal intussusception

(intussusception ≥10 mm) and/or rectocele extending 2 cm or more from the rectal wall contour, as shown by cinedefecography; and failure of 6 months of

medical therapy (2 L of water per day and high-fiber diet).

Exclusion criteria:

- previous anal and rectal surgery, intestinal inertia, anismus, associated II/III degree

genital prolapse, symptomatic cystocele, or any form of

anxiety or depression.

Intervention

STARR with 2 circular

staplers (PPH)

N = 31

Controls

STARR with the contour-curved stapler. (CCS)

N = 32

Primary outcomes:

ODS score, Wexner score

Secundary outcomes:

Follow up:

12 and 24 months

Primary outcomes:

The PPH group comprised 28 women and 2 men, with a mean age of 53 (SD, 5.2; range, 41–75) years; the CCS group comprised 29 women and 2men, with amean age of 55 (SD, 4.3; range, 38–69) years. The 2 groups did not differ with regard to preoperative ODS score: 15.2 (SD, 2.7) for PPH vs 15.5 (SD, 2.4) for CCS (2-sample T test, P = .64).

The mean operative time was 28.1 (SD, 11.5) minutes in the PPH group and 33.1 (15.7) minutes in the CCS group (P=.16; 2-sample T test). The mean length of postoperative hospital stay was 28 (SD, 12.5) hours in the PPH group and 30 (12.6) hours in the CCS group (P = .53; 2-sample T test).

At 24 months, an overall successful outcome as defined by ODS symptom scores was achieved in 21 patients (70.0%) in the PPH group and in 27 patients (87%) in the CCS group (P = .10).

Figure 3 shows the mean preoperative and postoperative Agachan-Wexner constipation scores in each group. At 12 months, constipation scores had improved in both groups and did not differ between the 2 groups (P= .33; 2-sample T test), whereas at 24 months constipation scores had worsened in the PPH group, resulting in a significant difference between groups (P= .03; 2-sample T test).

Clearly defined groups:

Yes

Selection bias:

No

Method of assessing the outcome

appropriately:

All patients underwent preoperative clinical evaluation, proctoscopy, and colonoscopy. The severity of ODS was assessed using the Obstructed Defecation Syndrome Score (ODS score). The validated Agachan-Wexner constipation scoring system was also administered. All operations (PPH and CCS groups) were performed by a single surgeon.

A procedure was considered successful when ODS scores were classed as excellent, good, or adequate, defined as follows: scores of 0 to 3 were classified as excellent, 4 to 6 as good, 7 to 9 as adequate, and 10 to 20 as poor.

Selective loss to follow up:

Two patients (3.2%), 1 in each study group, did not return after surgery; no postoperative data could be obtained for these patients.

Identification confounders and correction in analysis:

No

Funding:

This trial was not supported by any commercial

company.

Samaranayaka 2010

Design

Systematic review

N = 12 articles

Aim of the study:

This systematic review assesses the effectiveness

of ventral rectopexy (VR) surgery for treatment of

rectal prolapse (RP) and rectal intussusception (RI) in

adults.

Inclusion criteria

randomized controlled trials (RCTs) or nonrandomized studies in any language; more

than ten adult patients; receiving ventral mesh rectopexy surgery for RP or RI and stated outcome measures of

recurrence, constipation and ⁄ or FI rates of patients.

Exclusion criteria:

Intervention

Ventral rectopexy

N = 728 patients

Controls

No

N =

Primary outcomes:

recurrence, constipation and ⁄ or FI rates

Secundary outcomes:

Follow up:

Primary outcomes:

Clearly defined groups:

Yes

Selection bias:

Not applicable

Method of assessing the outcome

appropriately:

MEDLINE, EMBASE, Scopus and other relevant

databases were searched to identify studies. Randomized controlled trials or nonrandomized studies with more than 10 patients receiving ventral mesh rectopexy surgery were considered for the review.

Selective loss to follow up:

Not applicable

Identification confounders and correction in analysis:

Not applicable

Funding:

Not reported

Schiedeck 2005

Design

Cohort study

N = 150

Country

Germany

Aim of the study:

Therapeutic concept for rectal prolapse at a German institution

Inclusion criteria

- All patients who underwent elective laparoscopic surgery

for rectal prolapse within a 10-year period (January 1993

to November 2003)

Exclusion criteria:

Intervention

laparoscopic procedures for rectal prolapse

N = 150

Controls

No

Primary outcomes:

Recurrence reate

Secundary outcomes:

Follow up:

mean of 38 (range 8–120) months

Primary outcomes:

Conversion to open resection was necessary in three patients (2.0%). Thus,

laparoscopic operation could be completed in 147 patients (11 male, 136 female, mean age 64.4 (range 21–90) years) representing a laparoscopic completion rate of 98.0%.

Most common indication for surgery was rectal prolapse II–III0 combined with sigmoidocele (n=87, 59.2%), followed by rectal prolapse III0 (n=40, 27.2%) and rectal prolapse II–III0 combined with chronic diverticulitis (n=20, 13.6%). With regard to the degree of rectal prolapse, 50 patients had rectal prolapse II0 (34.0%), 71 had rectal prolapse III0 (48.3%), and 26 patients had rectal prolapse of different stages combined with outlet-obstruction by either sigmoidocele III0 or chronic diverticulitis (17.7%).

Most common procedure was laparoscopic resection–rectopexy, in 108 patients (73.3%), followed by suture rectopexy (n=32, 21.8%) and sigmoid resection (n=17,

11.9%). Intraoperatively, no complications associated with laparoscopy occurred.

Overall morbidity rate was 22.4% (n=33) including 25 patients with minor complications (17.0%) and eight with major complications (5.4%). Most common major complication requiring re-operation was hemorrhage, in four patients (2.7%). In terms of late-onset complications, two porthernias were diagnosed.

Follow-up study by telephone interview (90 of 150 patients available to date) showed recurrence of rectal prolapse in three of 90 patients (3.3%).

Clearly defined groups:

In our policy, the following classification

system is used: rectal prolapse I0 is defined by a

rectal intussusception above the anal canal (internal or incomplete prolapse); rectal prolapse II0 is an intussusception of the rectal wall into the anal canal, diagnosed by proctoscopy, whereas a complete (“full-thickness”) rectal prolapse through the anus is represented by rectal prolapse III0

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

Prospective follow-up included recurrence and was performed by telephone interview.

Selective loss to follow up:

Yes, follow-up available for 90 patients

Identification confounders and correction in analysis:

No

Funding:

Not reported

Tsunoda 2003

Design

Cohort study

N = 31

Country

Japan

Aim of the study:

was to investigate

the clinical, functional, and physiologic results of Delorme’s procedure.

Inclusion criteria

- patients with external rectal prolapse were treated by Delorme’s procedure at Showa University Hospital

between January 1994 and February 2002.

- No patient had undergone previous

surgery for rectal prolapse.

Exclusion criteria:

Intervention

Delorme’s procedure

N = 31

Controls

No

Primary outcomes:

Recurrence rate

Secundary outcomes:

Follow up:

median 39 (range

6–96) months.

Primary outcomes:

Their mean age was 70 (range, 14–93) years. The prolapse was full thickness, circumferential, and at least 5 cm.

Prolapse recurrence was observed in four patients, with a mean recurrence time of 14 (range, 3–25) months.

There were no postoperative deaths, but four patients died of nonrelated conditions

six months, one, two, and three years after the procedure, respectively. Minor postoperative complications occurred in four patients (minor dehiscence, wound infection, bleeding, fever).

The median (range) preoperative incontinence score in the remaining 26 patients significantly improved from 11.5 (1–20) to 6.0 (0–20) after operation (P < 0.0001)

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

Yes

Selective loss to follow up:

No

Identification confounders and correction in analysis:

No

Funding:

Not reported

Tou 2008

Design

Cochrane review and meta-analysis

N = 12 trials including 380 patients

Aim of the study:

To determine the effects of surgery on the treatment of rectal prolapse in adults.

Inclusion criteria

- All adults with rectal prolapse (through the anus) as diagnosed and

included by the trialists.

Exclusion criteria:

Intervention

See primary outcome

N =

Controls

See primary outcome

N =

Primary outcomes:

- number of patients with recurrent rectal prolapse,

- number of patients with

residual mucosal prolapse,

- number of patients with faecal incontinence or constipation.

Secundary outcomes:

- Participant symptoms

- Clinical end points

Follow up:

1 trial < year

11 trials 1-5 year

Primary outcomes:

Comparison 1. Surgical versus no intervention

There were no trials comparing surgery with no treatment.

Comparison 3. Abdominal versus perineal approach

One trial (Deen 1994) compared perineal rectosigmoidectomy and pelvic floor repair in 10 people with abdominal resection rectopexy and pelvic floor repair in another 10.

Comparison 4. Methods of performing rectopexy

4c. Preservation versus division of the lateral ligaments during open mesh rectopexy

Three small trials compared the effects of preservation versus division of lateral ligaments during open mesh rectopexy (Speakman 1991; Selvaggi 1993; Mollen 2000 NEW). The Selvaggi trial was available in an abstract format and datawere insufficiently reported to allow any statistical analyses to be performed.

Comparison 6. Laparoscopic versus open mesh rectopexy procedure

Laparoscopic mesh rectopexy was compared with open mesh rectopexy in two trials (Boccasanta 1998; Solomon 2002). There was a subsequent cost analysis for participants that were involved in the Solomon trial (Salkeld 2004).

Comparison 7. Resection versus no resection during rectopexy

Two small trials compared resection of redundant bowel in one group versus no resection in the other (both groups had a rectopexy). In one trial (Lukkonen 1992), resection was combined with suture rectopexy and compared with mesh rectopexy alone. In the other (McKee 1992), suture rectopexy was performed in

both groups but resection in only one group.

Clearly defined groups:

Yes

Selection bias:

Not expected

Method of assessing the outcome

appropriately:

They searched the Cochrane Incontinence Group Specialised Register (searched 10 January 2008), the Cochrane Colorectal Cancer Group Trials Register (searched 10 January 2008), CENTRAL (Issue 1, 2008), PubMed (1 January 1950 to 10 January 2008) and EMBASE (1 January 1998 to 10 January 2008). The British Journal of Surgery (January 1995 to January 2008) and the Diseases of the Colon and Rectum (January 1995 to January 2008) were specifically hand searched.

All randomised or quasi-randomised trials of surgery in the management of adult rectal prolapsed were selected.

Selective loss to follow up:

Not applicable

Identification confounders and correction in analysis:

No

Funding:

Not applicable

Youssef 2013

Design

RCT

N = 82

Country

Egypt

Aim of the study:

To compare Delorme operation alone or with postanal repair and levatroplasty in treating

complete rectal prolapse.

Inclusion criteria

- patients, who were treated for complete rectal prolapse at the

colorectal surgery unit of Mansoura University Hospital, Mansoura, Egypt, during

the period from January 2007 to June 2011

Exclusion criteria:

- pregnant female, any patients with previous anal surgery, pudendal

nerve neuropathy, anal fistula, and sepsis, age above 80 years, vascular disease, scleroderma, malnutrition, or coagulopathy.

Intervention

Delorme operation only (GI)

N = 41

Controls

Delorme

operation with postanal repair and levatorplasty (GII)

N = 41

Primary outcomes:

recurrence rate

Secundary outcomes:

improvement of constipation, incontinence, operative time, anal manometery and postoperative

complications

Follow up:

Primary outcomes:

Clearly defined groups:

Yes

Selection bias:

No

Method of assessing the outcome

appropriately:

All assessments were conducted by investigators who were blinded to the experimental condition.

A recurrence was defined as full-thickness protrusion of the neorectal bowel wall. The standardized Wexner constipation score was used to investigate the level of constipation before and after the operation. The Pescatori classification was used to grade fecal incontinence.

Selective loss to follow up:

3 women were loss to follow up

Identification confounders and correction in analysis:

No

Funding:

No financial disclosures