Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Ohazuruike, 2014

Type of study:

Prospective cohort

Setting:

Hospital care

Country:

Italy

Source of funding:

Not reported

Inclusion criteria:

the patients selected for surgery

were those with a failure of 6 months medical therapy

(1.5 L/day of water, high-fiber diet, lactulose 10 g/day)

the persistence of at least three symptoms of prolapse

Exclusion criteria:

Patients with non-relaxing puborectalis muscle at

defecography, with genital prolapse or cystocele requiring

associated transavaginal operations, fecal incontinence,

mental disorders or general contraindications to surgery

were excluded. Patients with pelvic floor dyssynergia were

treated with pelvic floor training.

N total at baseline:

Intervention: 23

Control: 12

Important prognostic factors²:

Age, median:

I: 52.6

C: 58.4

Sex:

I: 18% M

C: 17% M

Groups comparable at baseline?

No, patients with high risk of postoperative incontinence were considered for internal Delorme’s procedure. Patients selected for Delorme’s procedure had less functional symptoms, they had significant lower ODS-scores compared to the STARR group (p=0.02).

STARR

Internal Delorme

Length of follow-up:

Median follow-up was 15 (range 10–21) months and

postoperative follow-up was performed at 7–15, 30 days, 3

and 6 months.

Loss-to-follow-up:

Not reported.

Incomplete outcome data:

Not reported

Outcome measures and effect size:

Symptoms

Wexner-score (pre- and postoperatively)

I: pre 17.0; post 4.7

C: pre 15.3; post 3.3.

p-value (17.0 versus 15.3)=0.45

p-value (4.7 versus 3.3)=0.12

Obstructed defecation:

Defined as: Altomare ODS score (pre- and postoperatively)

I: pre 18.2; post 5.5

C: pre 16.5; post 5.3

p-value (18.2 versus 16.5)=0.56

p-value (5.5 versus 5.3)=0.87

Postoperative pain

Measured with VAS after 1, 3 and 6 months

I/C: NS.

Operative time, minutes:

I: 28 minutes

C: 56 minutes

P=0.0001

Abbreviations:

ODS=obstructed defecation syndrome

NS=not significant

STARR=stapled transanal rectal resection

Author’s conclusions:

Both ID and STARR procedure seem to be effective in the treatment of ODS. Internal Delorme should be considered for patients with high risk of postoperative continence alteration.

Mäkelä-Kaikkonen, 2013

Study design:

Matched cohort study

Setting and Country:

Italy

Source of funding:

None reported.

Conflicts of interest: none.

Inclusion criteria

Patients with rectal prolapse or intussusception elective for surgery between March 2011 and December 2011

Exclusion criteria:

Not specified

Important patient characteristics at baseline:

N, mean age, sex

I: N=20, 60.7 (SD 17.4), 15% male

C: N=20, 60.4 (SD 17.0), 15% male

The groups did not differ in terms of age, body mass index,

ASA classification, number of previous abdominal operations

or chronic illnesses

Intervention:

Robotic-assisted ventral rectopexy (N=20):

N=13 total rectal prolapse; N=7 intussusception (=IRP)

Control

Laparoscopic ventral mesh rectopexy (N=20):

N=14 total rectal prolapse;

N=6 intussusception (=IRP)

Length of follow-up:

3 months

Loss-to-follow-up:

None, no drop-outs

Incomplete outcome data:

None, no drop outs

Outcome measures:

Complications/recurrence (after 3 months)

I: 5% (n=1) continued to have symptoms of faecal incontinence; 5% (n=1) felt the symptoms worsened

C: 5% (n=1) recurrence was diagnosed. (p=1.0)

Operating time

Mean (±SD)

I: 159 minutes (37)

C: 153 minutes (33)

P=0.45

Author’s conclusions:

Our experience is in agreement with previous reports that

robotic-assisted laparoscopic ventral rectopexy is safe and

feasible.

There must be patient benefits to justify the additional

costs of robotic surgery.

Evidence assessment:

High risk of bias, small study, short follow-up time

Comments:

The intervention group was selected in 2011, the controls were selected from registry files of operations that had took place between 2008-2011

Young, 2015

Type of study:

Retrospective cohort-study

Setting:

American College of Surgeons

(ACS) National Surgical Quality Improvement Program

(NSQIP) database, data of 500 hospitals

Country:

USA

Source of funding:

Dr. Stamos has received educational grants and speaker

fees paid to the Department of Surgery, University of California,

Irvine, from Ethicon, Gore, Covidien, and Olympus. Dr. Mills and Dr.

Carmichael received Ethicon educational grants paid to the Department

of Surgery, University of California, Irvine. Dr. Pigazzi is a

consultant for Intuitive Surgical and has also received consultancy fees and educational grants paid to the Department of Surgery, University

of California, Irvine.

Inclusion criteria:

-patients diagnosed with rectal prolapse (ICD9: 569.1)

Exclusion criteria:

-Patients who underwent

emergent procedure

N total at baseline:

Intervention:

Laparoscopic: 729

Open: 966

Control: 1559 (perineal)

Important prognostic factors²:

Age:

Laparoscopic: 58 ± 18

Open 58 ± 17

C: 76 ± 15

Sex:

Laparoscopic: 11.34 % M

Open: 9.83 % M

C: 7.78 % M

Groups comparable at baseline?

Patients

undergoing PR were older (mean age 76 years), and had a higher mean ASA class (2.7) compared to patients undergoing

laparoscopic (58 years, 2.2) and open abdominal

procedures (58 years, 2.3).

The laparoscopic abdominal group

had significantly less female patients compared to the perineal group (89 versus 92 %, p\0.05). The

overall comorbidity count was significantly higher for the PR group, with an average of 1.2 comorbidities per patient, compared to 0.72 in the laparoscopic group, and 0.8 in the open group.

Interventions:

Open abdominal group:

open rectopexy (OR), open

resection/rectopexy (ORR),

Laparoscopic surgery:

laparoscopic rectopexy (LR), laparoscopic

resection/rectopexy (LRR),

Control:

Perineal surgery:

perineal resection (PR).

Follow-up:

Not applicable; missing demographic data were excluded from analysis

Outcome measure:

Multivariate analysis:

ORR had higher odds of morbidity compared to PR:

1.89, 95%CI (1.19-2.99) p=0.03

The other interventions were not significant:

-OR versus PR: 1.5, 95%CI (0.95-2.38) p=0.18

-LRR versus PR: 1.55, 95%CI (0.86-2.77) p=0.18

-LR versus PR: 0.44, 95%CI (0.19-1.03) p=0.18

Univariate analysis:

Readmission:

Laparoscopic: 1.28. Control 1.46 (not significant)

Open: 1.37. Control 1.46 (not significant)

30 day morbidity:

Laparoscopic: 9.6. Control 9.81 (not significant)

Open: 16.67. Control 9.81 (p<0.05)

30 day mortality:

Laparoscopic: 0.41. Control 1.6 (p<0.05)

Open: 0.41. Control 1.6 (p<0.05)

Length of stay:

Laparoscopic: 4 ± 3. Control 4±5 (not significant)

Open: 6±5. Control 4±5 (p<0.05)

Subset analysis:

30 day morbidity

LRR: 13.96. Control 9.81 p=0.03)

30 day mortality

LRR: 0.57. Control 1.6 (p=0.21)

Complication rates restricted to 30-days.

Author’s conclusions:

Laparoscopic rectal prolapse surgery has comparable morbidity and mortality to perineal surgery

Lehur, 2008

Type of study

Multi-centre RCT

Setting

Surgical centres

Country

France, Italy and UK

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

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 interviewed

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.

-former treatment of biofeedback

N total at baseline

I: 59

C: 60

Important prognostic factors²:

Age mean (SD)

I: 56 (9.2)

C: 56 (14.3)

Groups comparable at baseline?

Not clear, no information about comorbidities at baseline.

Rectocele present N(%)

I: 49 (92%)

C: 38 (97%)

Intussusception present:

I: 33 (61%)

C: 20 (51%)

Intervention

STARR

Controls

Twice per week electromyographic-based biodfeedback training for three months. Minimum of 10, maximum of 24 one-hour training.

Length of follow-up:

12 months

Loss-to-follow-up:

I: 14% (8/59)

C: 50% (30/60)

Five patients randomized to the STARR group did

not undergo surgery (lost to follow-up before treatment:

2, recommendation of the investigator: 1, consent

withdrawal: 1, other: 1) and eight patients allocated to

the BF group underwent no training (lost to follow-up

before treatment: 3, consent withdrawal: 4, other: 1).

Other reasons for withdrawal in BF group: unsatisfactory results

Incomplete outcome data:

Fifty-four STARR patients (91.5 percent) and 39 (65

percent) BF patients had evaluable data at the end of the

study (evaluable population (EP)), and 31 (52.5 percent)

STARR patients and 19 (31.7 percent) BF patients formed

the per-protocol population (PPP; Fig. 2).

Primary outcomes: ODS score, PAC-QOL, continence grading scale

Successful treatment, defined as a decrease in ODS score of ≥50 percent at one year was observed in 44 (81.5 percent) STARR patients compared with only 13 (33.3 percent) evaluable patients who received BF training (difference between groups 48.1 percent; P<0.0001; 95 percent confidence interval (CI), 30.1–66.2)

The Patient Assessment of Constipation Quality of Life showed significant reductions in both groups: total mean score (SD)

I: 63.9 (18.5) at baseline; 27.9 (25.1) after 12 months (p<0.0001)

C: 55.9 (22) at baseline; 44.8 (23.7) after 12 months (p=0.002)

Adverse events: 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.

Comments

High loss-to-follow-up.

Per-protocol analysis of available data.

Authors conclusion:

In this controlled trial, stapled transanal

rectal resection was well tolerated, was more effective than

biofeedback training for the resolution of obstructed

defecation symptoms, and improved quality of life, with

minimal risk of impaired continence. Thus, stapled

transanal rectal resection offers a new treatment alternative

for obstructed defecation after failure of conservative

measures including biofeedback training, a non-invasive

approach.

Renzi, 2011

Type of study

RCT

Setting

Regional referral centres

Country

Italy

Source of funding

This trial was not supported by any commercial

company.

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.

N total at baseline

I: 31

C: 32

Important prognostic factors²:

Age: mean (SF)

I: 53 (5.2)

C: 55 (4.3)

Sex: % male

I: 6.7%

C: 6.5%

Nulliparious

I: 5/28 women (10 of 23 women who gave birth had at least 1 vaginal delivery)

C: 6/29 women (8 of 23 women had who gave birth had at least 1 vaginal delivery)

Groups comparable at baseline?

Yes: the 2 groups did not differ with regard to preoperative ODS score: 15.2 (SD, 2.7) for PPH versus 15.5 (SD, 2.4) for CCS (2-sample T test, P=.64).

Results of preoperative manometry and

cinedefecography did not differ between the groups

Intervention

STARR with 2 circular

staplers (PPH)

Controls

STARR with the contour-curved stapler. (CCS)

Length of follow-up:

12 and 24 months

Loss-to-follow-up:

I: n=1

C: n=1

Reasons:

Patients did not return after surgery and postoperative data could not be obtained for these patients.

Incomplete outcome data:

See loss-to-follow-up

Outcomes

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).

The mean preoperative and postoperative Agachan-Wexner constipation scores at 12 months 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) (figure 3)

Complications were not different in both groups. In the PPH-group, 11 patients had early complications 7 had late complications; in the CCS-group 12 had early complications and 6 had late complications. (table 3)

Comments

Low risk of bias.

Stapled transanal rectal resection with

either circular or contour-curved staplers can achieve

relief of symptoms in patients with obstructed defecation

syndrome. The contour-curved stapler appears to result in more stable clinical results over time.

Isbert, 2009

Type of study

Cohort study

Setting:

Surgical department

Country

Germany

Source of funding

Not reported

Inclusion criteria

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

Exclusion criteria:

Non reported

N total at baseline

I: 68

C: 82

Important prognostic factors²:

Age: mean (SD)

I: 65 (14.2)

C: 66 (15.1)

Prior hysterectomy:

I: 83%

C: 81%

Multiparious:

I: 71%

C: 73%

Previous episotomy

I: 65%

C: 68%

Incontinence and constipation scores did not differ between the groups. There were slightly more patients with intussusception

(n=66, 80%) and enterocele (n=43, 53%) in the CT group as compared with the PPH-STARR

group intussusception (n=44, 65%);

Groups comparable at baseline?

Probably not: is unlikely that the groups were equally matched in terms of the degree of rectal intussusception

treated. With the introduction of CT, this procedure was preferred over the PPH-STARR technique when large

prolapses were encountered at operation.

Intervention

PPH-STARR

Controls

CT-STARR

Length of follow-up:

12

Loss-to-follow-up:

I: 18 (42%)

C: 44 (54%)

Reasons not reported

Incomplete outcome data:

See loss-to-follow-up

Functional 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.

Cleveland clinical score of incontinence

I: 4.19 baseline; 3.82 at 12 month (not sign)

C: 3.99 at baseline; 4.04 at 12 month (not sign)

Cleveland Constipation Score:

I: 15.5 at baseline, 8.25 at 12 months (not sign)

C: 15.7 at baseline, 8.01 at 12 months (not sign)

Complications

I: 8% (n=5)

C: 7% (n=6)

Comments

High loss-to-follow-up

All data were treated as non-parametric. No multi-variate analysis was done to correct for confounding.

No difference in outcomes between the groups.

Boccasanta,2011

Type of study

RCT

Setting

Department of general surgery

Country

Italy

Funding:

No financial disclosure

Inclusion criteria

• women with 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)

• Concomitant enterocele, compressing the rectum during

evacuation efforts

• Concomitant cystocele, or genital prolapse

• Psychiatric diseases

• Absolute contraindications to surgery.

N total at baseline

I: 50

C: 50

Important prognostic factors²:

Age: mean (range)

I: 57.1 (31–74)

C: 54.8 (27-77)

Multi-parity

I: 64% (n=32); mean: 2.63 ± 0.61

C: 66% (n=33) mean 2.67 ± 0.74

P=0.8

Hysterectomy:

I: 11 (22.0%)

C: 12 (24.0%)

2^nd degree prolapse:

I: 29/50

C: 30/50

P=0.84

pre-operative ODS scores, mean (SD)

I: 20.88 (1.35)

C: 20.6 (1.84) not sign.

Groups comparable at baseline?

Yes, probably comparable based on available data.

Intervention

stapled transanal rectal resection with a new, curved multifire stapler

(TRANSTAR group).

Controls

stapled transanal rectal resection with

2 traditional circular staplers (STARR group)

Length of follow-up:

Mean (SD)

I: 36.2 ± 4.2 months

C: 36.3 ± 4.4 months

Loss-to-follow-up:

None

Incomplete outcome data:

None

Primary outcomes:

Recurrence:

ODS-score >5

I: 0 (0%) C: 6 (12%) (X²=4.433; P=.035).;

Multivariate analysis for factors affecting recurrence

showed a direct association with preoperative (P=.004)

and postoperative (P=.009) descent of intussusception

and an indirect association with the weight of resected tissue

(P=.005).

Pain:

Mean (SD) VAS-score during hospital stay

I: 3.3 (0.6)

C: 3.5 (0.6) p=0.07

SF-36 Health Survey:

Surgery significantly improved quality of life in both groups (P 0.01), without differences.

Functional outcomes

Mean (SD) ODS-score post-operative (3 year)

I: 3.14 (1.63)

C: 3.52 (1.72) (not sign)

Fecal urgency (pre-operative in both groups 0) post-operative:

I: 14 % (n=7)

C: 34% (n=17)

P=0.035

Complications

I: 1 lesion of the vagina with TRANSTAR.

C: 2 bleeds (1 reoperation and 1 transfusion) with STARR

Comments

Author’s conclusion:

The curved Contour Transtar stapler device did not appear to offer significant advantages over the traditional PPH-01 device during the operation or in the clinical and functional outcomes. However, the lower incidence of fecal urgency and recurrences might justify the higher cost of the new stapler

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Lehur, 2008

Patients were enrolled in the study and were

randomized to one of the study arms, stratified 1:1 by

surgeon, with varying block sizes after baseline assessment.

Patients randomized to surgery at each center were all treated by the same surgeon.

Unclear

Likely, treatment was not possible for blinding

Likely, treatment was not possible for blinding

Likely, treatment was not possible for blinding

Unlikely, all predefined outcome measures were reported.

Likely, in the control-group, a loss-to-follow-up was 50%, in the intervention group 14%

Likely, violation of ITT; ‘Any patient who failed to complete the 12-

month assessment (15 months after start of treatment) within the time frame prescribed by the study protocol

(±2 weeks) was excluded from the per protocol analysis

Renzi, 2011

Randomization took place immediately

before the operation, after administration of subarachnoid

anesthesia. The randomization list was

computer generated, with block size varying from 4 to 6

patients.

Unlikely, patients were

randomly assigned by extracting the next opaque envelope in the

sequence.

Unlikely, all recruited patients and researchers involved in data

collection and analysis were blinded to the assigned operative

procedure.

Likely, surgeons were not blinded after randomization was assigned (not possible)

Unlikely, all recruited patients and researchers involved in data

collection and analysis were blinded to the assigned operative

procedure.

Unlikely, all predefined outcome measures were reported.

Unlikely, loss to follow op very low, reasons described

Likely, violation of ITT

Boccansante, 2011

Random permuted blocks were used with sizes varying from 4 to 6 and sequentially numbered. Sealed

envelopes with a random-number table were produced.

Unclear, whether envelopes were transparent or not.

Unclear

Unclear

Unclear whether the author who did post-operative measurements was blinded to the outcome

Unlikely, all predefined outcome measures were reported.

Unlikely, no loss to follow up

Unlikely, ITT analysis was followed.

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?¹

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?²

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?³

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?⁴

(unlikely/likely/unclear)

Ohazuruike, 2014

Likely, patients with high risk of postoperative incontinence were considered for internal Delorme’s procedure.

Unclear, only information is postoperative follow-up after 7-15, 30 days and 3, 6 months

Likely, no blinding of outcomes for surgeon/patient.

Likely, seems to be an univariate analysis

Young, 2015

Likely, selection bias based on whether a patient is deemed high-risk by the operating surgeon.

Likely, follow-up restricted to 30-day post-operative morbidity.

Likely, no blinding of outcomes for surgeon/patient.

Unlikely, adjustment in multivariate analysis

Mäkelä-Kaikkonen, 2013

Likely, selection bias by surgeon

Unlikely, follow-up after three months, no drop-outs

Likely, no blinding of outcomes for surgeon/patients

Likely, no multivariate analysis.

Isbert, 2009

Likely, the groups were not equally matched in terms of the degree of rectal intussusception

treated. With the introduction of CT, this procedure was preferred over the PPH-STARR technique when large

prolapses were encountered at operation.

Likely, high number of loss-to-follow-up, reasons not reported

Likely, no blinding of outcomes for surgeon or patients.

Likely, no multivariate analysis