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Methods of repair for obstetric anal sphincter injury

  1. Ruwan J Fernando1,*,
  2. Abdul H Sultan2,
  3. Christine Kettle3,
  4. Ranee Thakar2

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 8 DEC 2013

Assessed as up-to-date: 2 OCT 2013

DOI: 10.1002/14651858.CD002866.pub3


How to Cite

Fernando RJ, Sultan AH, Kettle C, Thakar R. Methods of repair for obstetric anal sphincter injury. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD002866. DOI: 10.1002/14651858.CD002866.pub3.

Author Information

  1. 1

    St Mary's Hospital, Imperial College Healthcare NHS Trust, Department of Urogynaecology, London, UK

  2. 2

    Croydon University Hospital NHS Trust, Department of Obstetrics and Gynaecology, Croydon, UK

  3. 3

    Staffordshire University, Faculty of Health Sciences, Staffordshire, UK

*Ruwan J Fernando, Department of Urogynaecology, St Mary's Hospital, Imperial College Healthcare NHS Trust, Praed Street, London, W2 1NY, UK. ruwan.fernando@imperial.nhs.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 8 DEC 2013

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Characteristics of included studies [ordered by study ID]
Farrell 2012

MethodsBlock sized computerised randomisation.


Participants123 women who had complete 3rd degree or 4th degree perineal tears in a single tertiary care academic centre.

Parity: primipara only.

Mean age: overlap group: 29.6 years. End-to-end group: 28.8 years.

Operators: obstetricians trained in both methods.


InterventionsMethod of repair:
participants divided in to 2 groups:
1. overlap repair of EAS using 3-0 Polyglyconate sutures (n = 61);
2. end-to-end repair of EAS using 3-0 Polyglyconate sutures (n = 62).


Outcomes1. Flatal incontinence at 6 months (primary outcome).
2. Faecal incontinence at 6,12, 24 and 36 months.
3. Quality of life scales based on Rockwood 2000 at 6 months.
4. Anal manometry at 6 months.

5. Anal sphincter defects detected by endoanal ultrasonography at 6 months


NotesMethod of repair: described.

Exclusion criteria: described.

Inclusion criteria: described.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskWomen were assigned randomly to overlapping or end-to-end EAS repair using a computer-generated block size that varied at random (2, 4, or 6). Each randomisation required logging into a secure, password-protected web site.

Allocation concealment (selection bias)Low riskWomen were assigned randomly to overlapping or end-to-end EAS repair using a block size that varied at random (2, 4, or 6) to prevent the ability to predict the group to which the next patient would be assigned. Each randomisation required logging into a secure, password-protected web site. The allocation sequence was determined by a computer algorithm.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskAll study investigators, including the statistician, were blind to the allocation code until the final analysis. The interim analysis was presented by the statistician (with types of surgical repair labelled A and B) to an independent oversight committee whose task was to review any adverse events and instruct the investigators to either stop or continue the study.

Both the women and follow-up assessment personnel were blinded to the surgical procedure performed. The women were advised, as part of the consent process, that this blinding was necessary to avoid biasing the results. The healthcare personnel who performed the follow-up evaluations did not have access to the woman’s chart for the duration of the study.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskFollow-up assessment personnel were blinded to the surgical procedure performed. The healthcare personnel who performed the follow-up evaluations did not have access to the woman’s chart for the duration of the study.

Incomplete outcome data (attrition bias)
All outcomes
Low risk8/174 (4%) of women lost to follow-up. The study clearly documented the steps taken to minimise the loss to follow-up.

Selective reporting (reporting bias)Low riskAll participants are accounted for including those lost to follow-up.

Other biasLow riskNo evidence of other bias in the study identified.

Fernando 2006

MethodsComputer randomisation using minimisation.


Participants64 women with 3b, 3c and 4th degree perineal tears following vaginal delivery at a hospital in Stoke-on-Trent, England.

Parity: primiparae and multiparae.

Mean age: 39.8.

Operators: 2 trained clinicians.


InterventionsMethod of repair:
participants divided in to 2 groups:
1. overlap repair of EAS using 3-0 Polydiaxanone sutures (n = 32);
2. end-to-end repair of EAS using 3-0 Polydiaxanone sutures (n = 32).


Outcomes1. Faecal incontinence at 12 months (primary outcome).
2. Faecal incontinence at 6 weeks, 3, 6 and 12 months.
3. Faecal urgency at 6 weeks, 3, 6 and 12 months.
4. Dyspareunia at 3, 6 and 12 months.
5. Perineal pain at 6 weeks, 3, 6 and 12 months.
6. Improvement of anal incontinence from 6 weeks to 12 months.
7. Mean anal incontinence score (based on Vaizey 1999).
8. Quality of life scales based on Rockwood 2000.
9. Anal manometry at 6 and 12 months.
10. Anal sphincter defects detected by endoanal ultrasonography at 6 and 12 months.


NotesMethod of repair: described.

Exclusion criteria: described.

Inclusion criteria: described


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe study was designed as a parallel group randomised controlled study with minimisation for parity, gestation, and mode of delivery using a customised computer package that minimised the possibility of unequal distribution of confounding factors between the 2 groups, which otherwise would have affected the outcome. Use of “minimisation” rather than random permuted blocks for treatment allocation ensured that the 2 groups were similar and that confounding factors were evenly distributed.

Allocation concealment (selection bias)Low riskThe customised computer randomisation package was password-protected to ensure concealment of treatment allocation.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants were blinded to the method of suturing.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskClinicians who performed endoanal ultrasound and anal manometry were blinded to the method of repair and were unaware of the clinical outcome.

Incomplete outcome data (attrition bias)
All outcomes
Low risk12 out of 64 (19%) women in study were lost to follow-up. The study clearly documented the steps taken to minimise the loss to follow-up.

Selective reporting (reporting bias)Low riskAll participants are accounted for including those lost to follow-up.

Other biasLow riskNo evidence of other bias in the study identified.

Fitzpatrick 2000

MethodsSealed-envelope randomisation.


Participants112 women with 3rd and 4th degree perineal tears following vaginal delivery at a hospital in Dublin, Ireland.

Parity: primigravidae.

Mean age: not reported.

Operators: experienced clinicians.


InterventionsMethod of repair:
participants divided into 2 groups:
1. overlap repair of EAS using 2-0 Maxon sutures (n = 55);
2. end-to-end repair of EAS using 2-0 Maxon sutures (n = 57).


OutcomesIncluded in analysis:
1. Faecal incontinence symptoms at 3 months.
2. Fecal urgency at 3 months.
3. Median continence score at 3 months (based on Jorge 1993).
4. Perineal pain (sub-divided in to discomfort, apareunia and need for perineal injection of hyaluronidase and methylprednisolone) at 3 months.
5. Anal manometry (median resting pressure, median squeeze pressure, median squeeze increment, vector symmetry index) at 3 months.
6. Anal sphincter defects detected by endoanal ultrasonography at 3 months.


NotesMethod of repair: described.

Exclusion criteria: described.

Inclusion criteria: described.

Grades of 3rd degree tears were not described. Grade 3a tears can not be repaired by overlap technique unless the sphincter is completely divided. This aspect is not clarified in this study.

IAS was not separately repaired.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo mentioned about the random sequence generation.

Allocation concealment (selection bias)Unclear riskA sealed randomisation envelope was used - but no mention if envelopes were opaque.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo mention about the blinding of the participants or the clinicians performing the repair.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo mention about the blinding of the participants or the clinicians performing the investigations. Primary investigator carried out the endoanal scans under supervision. Not clear whether the primary investigator carried out the repair.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo evidence about the steps taken to minimise the lost to follow-up.

Selective reporting (reporting bias)Unclear riskNo evidence about the steps taken to minimise the lost to follow-up.

Other biasLow riskNo evidence of other bias in the study identified.

Garcia 2005

MethodsSealed numbered opaque envelope randomisation


Participants41 women with complete 3rd and 4th degree perineal lacerations at a hospital in New Mexico, USA.

Parity: 30 primiparous and 11 multiparous women.

Mean age: 25.9 years

Operators: Resident physicians under supervision of attending physician


InterventionsMethod of repair:
participants divided into 2 groups:
1. overlap repair of EAS using 2-0 polydiaxanone sutures (n = 18);
2. end-to-end repair of EAS using 0 Polyglycolic acid sutures (n = 23).


OutcomesSymptoms based on Faecal Incontinence Score


NotesMethod of repair: described.

Exclusion criteria: described.

Inclusion criteria: described


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation tables were used to produce sealed opaque sequentially numbered envelopes.

Allocation concealment (selection bias)High risk9/51 (18%) envelopes were opened without randomisation. Authors could not give an explanation.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot clear whether the participants were blinded to the method of suturing

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPostpartum evaluators were blinded for the repair technique.

Incomplete outcome data (attrition bias)
All outcomes
High risk15/41 (37%) women in the study were lost to follow-up. The study clearly documented the steps taken to minimise the loss to follow-up, but not all the participants were accounted for including those lost to follow-up.

Selective reporting (reporting bias)High riskNo clearly defined primary outcome measure. Not all the participants were accounted for including those lost to follow-up.

Other biasHigh risk1. Different types of sutures used in 2 techniques (overlap repair using 2-0 polydiaxanone sutures and end-to-end repair using 0 Polyglycolic acid sutures.

2. Follow-up range between 4 weeks to 9 months (mean 3+/-2.5 months).

3. 4 women with flatal incontinence and 1 woman with solid stool incontinence prior to delivery were included in the analysis.

4. No clearly defined primary outcome measure.

Rygh 2010

MethodsSealed numbered opaque envelope randomisation.


Participants119 women with 3b, 3c and 4th degree perineal tears following vaginal delivery at a hospital in Stavanger, Norway.

Parity: primiparae and multiparae.

Mean age: 29.

Operators: trained clinicians and trainees under supervision of a trained clinician.


InterventionsMethod of repair:
participants divided into 2 groups:
1. overlap repair of EAS using 3-0 PDS sutures (n = 59);
2. end-to-end repair of EAS using 3-0 PDS sutures (n = 60).


Outcomes1. Leakage of solid stools once a week or more at 12 months (primary outcome).

2. Leakage of liquid stools once a week or more at 12 months.

3. Flatus incontinence once a week or more at 12 months.

4. Dyspareunia once a month or more at 12 months.

5. Mean Wexner score at 12 months.

6. Continence status based on Wexner score (Continent - Wexner Score ≤ 5, Anal incontinence - Wexner score 6-9, Severe anal incontinence - Wexner score ≥ 10).

7. Anal manometry at 12 months.
8. Anal sphincter defects detected by endoanal ultrasonography at 12 months.


NotesMethod of repair: described.

Exclusion criteria: described.

Inclusion criteria: described.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSealed, numbered, opaque envelope containing random generated numbers. Information about the method to be used had been put into envelopes; equal numbers for each method; and the envelopes were sealed, numbered and mixed by an independent person.

Allocation concealment (selection bias)Low riskThe obstetrician randomly picked a sealed, numbered, opaque envelope containing the information of the method of repair. Information about the method to be used had been put into envelopes; equal numbers for each method; and the envelopes were sealed, numbered and mixed by an independent person.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipating patients were blinded with regard to the type of repair.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskClinicians who performed endoanal ultrasound and anal manometry were blinded to the method of repair and were unaware of the clinical outcome.

Incomplete outcome data (attrition bias)
All outcomes
Low risk18/119 (15%) women in the study were lost to follow-up. The study clearly documented the steps taken to minimise the loss to follow-up.

Selective reporting (reporting bias)Low riskAll participants are accounted for including those lost to follow-up.

Other biasLow riskNo evidence of other bias in the study identified.

Williams 2006

MethodsSealed-envelope randomisation.


Participants103 women with complete or partial 3rd degree tears and 4th degree tears following vaginal delivery in a hospital in Liverpool, England.

Parity: primiparae and multiparae.

Mean age: 29.


InterventionsParticipants were divided into 4 groups:
1. overlap repair with Vicryl (n = 28);
2. overlap repair with PDS (n = 28);
3. end-to-end repair with Vicryl (n = 28);
4. end-to-end repair with PDS (n = 28).


Outcomes1. Suture related morbidity at 6 weeks.

2. Bowel symptoms at 3, 6, and 12 months assessed by validated questionnaire.

3. Anorectal physiology at 3 months.

4. Quality of life scores assessed by validated questionnaire at 3 and 12 months.


NotesSetting: Liverpool, United Kingdom.

Method of repair: overlap and end-to-end.

Exclusion criteria: not available at the time of review.

Inclusion criteria: not available at the time of review.

Details of repair technique were not available at the time of review.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe randomisation sequence was generated using a table of random numbers in varied blocks of 4 and 8. Participants were randomised into 2 repair techniques and 2 suture materials.

Allocation concealment (selection bias)Low riskRandomisation was determined using sequentially numbered sealed opaque envelopes that contained a description of the repair method and suture material to be used.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBoth the women and the clinicians performing these investigations were blinded to the treatment allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo mention about the blinding of the clinicians performing the investigations.

Incomplete outcome data (attrition bias)
All outcomes
High risk43/103 (42%) women in the study were lost to follow-up. The study clearly documented the steps taken to minimise the loss to follow-up.

Selective reporting (reporting bias)Low riskAll participants are accounted for including those lost to follow-up.

Other biasLow riskNo evidence of other bias in the study identified.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Goh 2004The repair of EAS was not performed immediately after OASIS but was regarded as a secondary repair. In addition, these studies included some participants who had previous anal sphincter repair for anal incontinence and included postmenopausal women. It appears that participants from the Goh 2004 study were included in the Tjandra 2003 study.

Johansson 2005This is the abstract of Nordenstam 2008 trial that compares immediate versus delayed repair of OASIS.

Lindqvist 2010Non randomised study.

 
Characteristics of ongoing studies [ordered by study ID]
Johanson 2001

Trial name or titleThe REPAIR study: recognition and expertise of in the prevention of anal incontinence from ruptured sphincter.

Methods

ParticipantsAny woman postpartum with complete obstetric anal sphincter rupture (3rd or 4th degree perineal tear), where an experienced clinician is available to perform the repair.

Exclusions: women who have had previous surgery for obstetric repair or anal fistula.

InterventionsRepair of rupture.

OutcomesPrimary: anal incontinence one year after repair.

Secondary: perineal pain, anal incontinence and faecal evacuation problems at 10 days breastfeeding.

Starting dateOctober 2001 - April 2008

Contact informationLinda Lucking: linda@kogs.freeserve.co.uk

NotesEmailed authors to ascertain outcome of this trial. Results currently being written up for publication.

 
Comparison 1. Overlap versus end-to-end

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Faecal urgency2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Faecal urgency at 6 weeks
163Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.48, 2.46]

    1.2 Faecal urgency at 3 months
2172Risk Ratio (M-H, Fixed, 95% CI)0.68 [0.42, 1.09]

    1.3 Faecal urgency at 6 months
156Risk Ratio (M-H, Fixed, 95% CI)0.22 [0.05, 0.94]

    1.4 Faecal urgency at 12 months
152Risk Ratio (M-H, Fixed, 95% CI)0.12 [0.02, 0.86]

 2 Flatus incontinence4Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 Flatus incontinence at 6 weeks
163Risk Ratio (M-H, Random, 95% CI)0.48 [0.13, 1.77]

    2.2 Flatus incontinence at 3 months
2101Risk Ratio (M-H, Random, 95% CI)1.27 [0.56, 2.90]

    2.3 Flatus incontinence at 6 months
2205Risk Ratio (M-H, Random, 95% CI)1.58 [1.09, 2.31]

    2.4 Flatus incontinence at 12 months
3256Risk Ratio (M-H, Random, 95% CI)1.14 [0.58, 2.23]

    2.5 Flatus incontinence at 24 months
195Risk Ratio (M-H, Random, 95% CI)1.11 [0.74, 1.69]

    2.6 Flatus incontinence at 36 months
168Risk Ratio (M-H, Random, 95% CI)1.12 [0.63, 1.99]

 3 Faecal incontinence4Risk Ratio (M-H, Random, 95% CI)Subtotals only

    3.1 Faecal incontinence at 6 weeks
163Risk Ratio (M-H, Random, 95% CI)0.65 [0.20, 2.07]

    3.2 Faecal incontinence at 3 months
2101Risk Ratio (M-H, Random, 95% CI)0.84 [0.06, 12.73]

    3.3 Faecal incontinence at 6 months
2205Risk Ratio (M-H, Random, 95% CI)0.48 [0.02, 12.89]

    3.4 Faecal incontinence at 12 months
3256Risk Ratio (M-H, Random, 95% CI)0.37 [0.03, 4.68]

    3.5 Faecal incontinence at 24 months
195Risk Ratio (M-H, Random, 95% CI)0.88 [0.32, 2.41]

    3.6 Faecal incontinence at 36 months
168Risk Ratio (M-H, Random, 95% CI)1.01 [0.34, 2.98]

 4 Alteration in faecal continence2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Alteration in faecal continence at 6 weeks
163Risk Ratio (M-H, Fixed, 95% CI)0.73 [0.41, 1.27]

    4.2 Alteration in faecal continence at 3 months
2172Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.64, 1.14]

    4.3 Alteration in faecal continence at 6 months
156Risk Ratio (M-H, Fixed, 95% CI)0.82 [0.40, 1.66]

    4.4 Alteration in faecal continence at 12 months
152Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.18, 1.17]

 5 One or more anal incontinence symptoms (Faecal urgency, flatus incontinence, faecal incontinence, alteration in faecal continence) not prespecified outcome52221Risk Ratio (M-H, Random, 95% CI)0.90 [0.68, 1.17]

    5.1 One or more anal incontinence symptoms at 6 weeks
1252Risk Ratio (M-H, Random, 95% CI)0.75 [0.49, 1.16]

    5.2 One or more anal incontinence symptoms at 3 months
3505Risk Ratio (M-H, Random, 95% CI)0.80 [0.63, 1.03]

    5.3 One or more anal incontinence symptoms at 6 months
2522Risk Ratio (M-H, Random, 95% CI)1.00 [0.38, 2.62]

    5.4 All anal incontinence symptoms at 12 months
3616Risk Ratio (M-H, Random, 95% CI)0.73 [0.24, 2.20]

    5.5 One or more anal incontinence symptoms at 24 months
1190Risk Ratio (M-H, Random, 95% CI)1.06 [0.69, 1.61]

    5.6 One or more anal incontinence symptoms at 36 months
1136Risk Ratio (M-H, Random, 95% CI)1.08 [0.63, 1.85]

 6 Deterioration of anal incontinence symptoms141Risk Ratio (M-H, Fixed, 95% CI)0.26 [0.09, 0.79]

 7 Perineal pain2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    7.1 Perineal pain at 6 weeks
163Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.42, 2.26]

    7.2 Perineal pain at 3 months
2172Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.54, 1.34]

    7.3 Perineal pain at 6 months
156Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.03, 2.10]

    7.4 Perineal pain at 12 months
152Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.00, 1.45]

 8 Need for perineal injection at 3 months1112Risk Ratio (M-H, Fixed, 95% CI)0.96 [0.48, 1.91]

 9 Perineal pain/dyspareunia1Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 Perineal pain/dyspareunia at 6 weeks
1103Risk Ratio (M-H, Fixed, 95% CI)0.71 [0.27, 1.84]

    9.2 Perineal pain/dyspareunia at 3 months
189Risk Ratio (M-H, Fixed, 95% CI)1.79 [0.83, 3.84]

    9.3 Perineal pain/dyspareunia at 6 months
179Risk Ratio (M-H, Fixed, 95% CI)0.38 [0.11, 1.36]

    9.4 Perineal pain/dyspareunia at 12 months
160Risk Ratio (M-H, Fixed, 95% CI)0.35 [0.07, 1.66]

 10 Dyspareunia3Risk Ratio (M-H, Random, 95% CI)Subtotals only

    10.1 Dyspareunia at 3 months
2172Risk Ratio (M-H, Random, 95% CI)0.82 [0.26, 2.61]

    10.2 Dyspareunia at 6 months
156Risk Ratio (M-H, Random, 95% CI)0.86 [0.33, 2.23]

    10.3 Dyspareunia at 12 months
2151Risk Ratio (M-H, Random, 95% CI)0.77 [0.48, 1.24]

 11 Quality of life scale 1: lifestyle1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    11.1 Mean lifestyle scale at 6 weeks
163Mean Difference (IV, Fixed, 95% CI)0.10 [-0.12, 0.32]

    11.2 Mean lifestyle scale at 3 months
160Mean Difference (IV, Fixed, 95% CI)0.10 [-0.19, 0.39]

    11.3 Mean lifestyle scale at 6 months
156Mean Difference (IV, Fixed, 95% CI)0.0 [-0.20, 0.20]

    11.4 Mean lifestyle scale at 12 months
152Mean Difference (IV, Fixed, 95% CI)0.06 [-0.23, 0.35]

 12 Quality of life scale 2: coping and behaviour1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    12.1 Mean coping and behaviour scale at 6 weeks
163Mean Difference (IV, Fixed, 95% CI)0.10 [-0.19, 0.39]

    12.2 Mean coping and behaviour scale at 3 months
160Mean Difference (IV, Fixed, 95% CI)0.10 [-0.19, 0.39]

    12.3 Mean coping and behaviour scale at 6 months
156Mean Difference (IV, Fixed, 95% CI)0.20 [-0.06, 0.46]

    12.4 Mean coping and behaviour scale at 12 months
152Mean Difference (IV, Fixed, 95% CI)0.13 [-0.24, 0.50]

 13 Quality of life scale 3: depression and self-perception1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    13.1 Mean depression and self-perception scale at 6 weeks
163Mean Difference (IV, Fixed, 95% CI)0.30 [0.05, 0.55]

    13.2 Mean depression and self-perception scale at 3 months
160Mean Difference (IV, Fixed, 95% CI)0.0 [-0.23, 0.23]

    13.3 Mean depression and self-perception scale at 6 months
156Mean Difference (IV, Fixed, 95% CI)0.10 [-0.11, 0.31]

    13.4 Mean depression and self-perception scale at 12 months
152Mean Difference (IV, Fixed, 95% CI)0.0 [-0.26, 0.26]

 14 Quality of life scale 4: embarrassment1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    14.1 Mean embarrassment scale at 6 weeks
163Mean Difference (IV, Fixed, 95% CI)0.30 [0.06, 0.54]

    14.2 Mean embarrassment scale at 3 months
160Mean Difference (IV, Fixed, 95% CI)0.20 [-0.08, 0.48]

    14.3 Mean embarrassment scale at 6 months
156Mean Difference (IV, Fixed, 95% CI)0.20 [-0.04, 0.44]

    14.4 Mean embarrassment scale at 12 months
152Mean Difference (IV, Fixed, 95% CI)0.20 [-0.14, 0.54]

 15 Anal incontinence score1Std. Mean Difference (IV, Fixed, 95% CI)Subtotals only

    15.1 Anal incontinence score at 6 weeks
163Std. Mean Difference (IV, Fixed, 95% CI)-0.37 [-0.87, 0.13]

    15.2 Anal incontinence score at 3 months
160Std. Mean Difference (IV, Fixed, 95% CI)-0.19 [-0.70, 0.32]

    15.3 Anal incontinence score at 6 months
156Std. Mean Difference (IV, Fixed, 95% CI)-0.47 [1.00, 0.07]

    15.4 Anal incontinence score at 12 months
152Std. Mean Difference (IV, Fixed, 95% CI)-0.70 [-1.26, -0.14]

 16 Anal incontinence score > 104Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    16.1 Anal incontinence score > 10 at 6 weeks
2166Risk Ratio (M-H, Fixed, 95% CI)0.34 [0.06, 2.05]

    16.2 Anal incontinence score > 10 at 3 months
3275Risk Ratio (M-H, Fixed, 95% CI)0.43 [0.13, 1.46]

    16.3 Anal incontinence score > 10 at 6 months
2137Risk Ratio (M-H, Fixed, 95% CI)0.18 [0.02, 1.53]

    16.4 Anal incontinence score > 10 at 12 months
3211Risk Ratio (M-H, Fixed, 95% CI)0.31 [0.03, 2.91]