Repair of obstetric anal Repair of obstetric anal sphincter tearssphincter tears

Journal ClubJournal Club1818thth February 2011 February 2011

By Dr. Ian Haines GP-ST1By Dr. Ian Haines GP-ST1& Nevine te West& Nevine te West

Introduction: Obstetric anal Introduction: Obstetric anal sphincter tearssphincter tears• FIRST degree FIRST degree

• SECOND degreeSECOND degree

Introduction: Obstetric anal Introduction: Obstetric anal sphincter tearssphincter tears• THIRD & FOURTH degreeTHIRD & FOURTH degree

IntroductionIntroduction

• Repair of obstetric anal sphincter tears Repair of obstetric anal sphincter tears does not give optimal resultsdoes not give optimal results

• Which kind of repair is superior is an Which kind of repair is superior is an ongoing debate: end-to-end versus ongoing debate: end-to-end versus overlappingoverlapping

• Previous RCT by Sultan changed our Previous RCT by Sultan changed our practice as the overlapping technique was practice as the overlapping technique was found to give better results in anatomical found to give better results in anatomical structure, function and symptomsstructure, function and symptoms

• This paper shows opposite results to those This paper shows opposite results to those of Sultanof Sultan

Aims and ObjectivesAims and Objectives

AimAim: : • evaluation of results of overlapping technique evaluation of results of overlapping technique

versus end-to-end in repairing 3versus end-to-end in repairing 3rdrd degree degree obstetric anal sphincter tearsobstetric anal sphincter tears

ObjectiveObjective::• appraise paperappraise paper• determine validity of the paper, identify if the determine validity of the paper, identify if the

results are reliable enough to help answer the results are reliable enough to help answer the question and subsequently change clinical question and subsequently change clinical practice practice

• gain experience in critical appraisal of evidencegain experience in critical appraisal of evidence

The Clinical Question:The Clinical Question: In women with obstetric anal sphincter In women with obstetric anal sphincter tears, is overlapping or end to end technique tears, is overlapping or end to end technique more superior? more superior?

PopulationPopulation: : women with obstetric anal sphincter tearswomen with obstetric anal sphincter tears

InterventionIntervention:: end-to-end techniqueend-to-end technique

ComparisonComparison::overlappingoverlapping

OutcomeOutcome::flatal and faecal incontinence, integrity of flatal and faecal incontinence, integrity of anal sphincter on scan and its function by anal sphincter on scan and its function by manometrymanometry

Previous Review – Cochrane Previous Review – Cochrane review 2010 - 3 eligible trialsreview 2010 - 3 eligible trials

• Overlap associated with lower risk faecal Overlap associated with lower risk faecal urgency & anal incontinenceurgency & anal incontinence

BUTBUT

• Heterogeneity of studiesHeterogeneity of studies

• Variation of the outcome measuresVariation of the outcome measures

• Experience surgeons not addressedExperience surgeons not addressed

• Primiparous and multiparous includedPrimiparous and multiparous included

• Authors couldn’t recommend techniqueAuthors couldn’t recommend technique

Paper appraisedPaper appraised

• Overlapping Compared With End-to-End Overlapping Compared With End-to-End Repair of Third- and Fourth-Degree Repair of Third- and Fourth-Degree Obstetric Anal Sphincter Tears – Obstetric Anal Sphincter Tears – A Randomised Controlled TrialA Randomised Controlled Trial

• Obstetrics and Gynaecology Vol. 116, no. 1, Obstetrics and Gynaecology Vol. 116, no. 1, 16-24 July 2010 16-24 July 2010

• Scott A. Farrell, MD, Donna Gilmour, MD, Scott A. Farrell, MD, Donna Gilmour, MD, Geoffrey K. Turnbull, MD, Matthias H. Geoffrey K. Turnbull, MD, Matthias H. Schmidt, MD, Thomas F. Baskett, MD, Schmidt, MD, Thomas F. Baskett, MD, Gordon Flowerdew, PhD, and Cora A. Gordon Flowerdew, PhD, and Cora A. Fanning, BNFanning, BN

Study DesignStudy Design

• Randomised controlled trialRandomised controlled trial

• Chose to appraise this article on Chose to appraise this article on request of Mr Parsons as a request of Mr Parsons as a randomised controlled trial and randomised controlled trial and different conclusion to previous different conclusion to previous studies on suturing of 3studies on suturing of 3rdrd degree degree tearstears

Methods -1Methods -1

• Randomised controlled trial comparing Randomised controlled trial comparing overlapping to end-to-endoverlapping to end-to-end

• Appropriate sample size calculationAppropriate sample size calculation• Only primiparous women included with Only primiparous women included with

total 3total 3rdrd degree or 4 degree or 4thth degree tears degree tears• Computerised randomisation & allocationComputerised randomisation & allocation• Study investigators, statistician, patients Study investigators, statistician, patients

and follow up investigators blindedand follow up investigators blinded

Methods -2 Methods -2

• Protocol approved by health care centre Protocol approved by health care centre boardboard

• Women consented on 2 occasionsWomen consented on 2 occasions

• Primary outcome: flatal incontinence at 6/12Primary outcome: flatal incontinence at 6/12

• Secondary outcome: faecal incontinence, Secondary outcome: faecal incontinence, quality-of-life scores, anal ultrasound for quality-of-life scores, anal ultrasound for internal & external anal sphincter integrity, internal & external anal sphincter integrity, anal manometry for anal sphincter functionanal manometry for anal sphincter function

Flow chart of studyFlow chart of study

ResultsResults

• 149 primiparous women: 75 end-to-end & 74 149 primiparous women: 75 end-to-end & 74 overlapping with similar baseline characteristicsoverlapping with similar baseline characteristics

- Overlapping > rate flatal incontinenceOverlapping > rate flatal incontinence 61% vs 39% OR 2.44 CI 1.2-5.0 (significant)61% vs 39% OR 2.44 CI 1.2-5.0 (significant)- Overlapping > rate faecal incontinence Overlapping > rate faecal incontinence

15% vs 8% not (significant)15% vs 8% not (significant)- Internal & external sphincter defects not Internal & external sphincter defects not

significantly differentsignificantly different- Anal sphincter function with manometry not Anal sphincter function with manometry not

significantly differentsignificantly different

GATE FrameGATE Frame

OutcomeFaecal incontinence

End-to-end(75)

Overlapping(74)

Intervention

Comparison

Participants

Source population

Primiparous women with 3rd or 4th degree

tears

Present Absent

Eligible population 671

Participants 149 (25)

5(8%)

(92%)

9 (15%)

(85%)

Author’s conclusionAuthor’s conclusion

• End-to-end lower rates anal incontinenceEnd-to-end lower rates anal incontinence• Advise end-to-end techniqueAdvise end-to-end technique• Possibility greater denervation & scarring of eas Possibility greater denervation & scarring of eas

during dissection for overlap repairduring dissection for overlap repair• Advantages of their study: Advantages of their study: - Only primparous womenOnly primparous women- Only complete eas tearsOnly complete eas tears- Clear objectives & measures of outcomeClear objectives & measures of outcome• Disadvantages:Disadvantages:- ? Validated questionnaires (not mentioned)? Validated questionnaires (not mentioned)- Surgeon’s experience greater in end-to-end groupSurgeon’s experience greater in end-to-end group

Critical AppraisalCritical Appraisal

• GATE FrameGATE Frame

• RAMMBORAMMBO

RAMMboRAMMbo

RAMMbo is the acronym used to RAMMbo is the acronym used to appraise studies:appraise studies:o RecruitmentRecruitmento AllocationAllocationo MaintenanceMaintenanceo MeasurementsMeasurements

•blindedblinded

•objective objective

RAMMbo - RecruitmentRAMMbo - Recruitment

Were the subjects representative of the Were the subjects representative of the target population?target population?• Yes, all subjects experienced 3Yes, all subjects experienced 3rdrd or 4 or 4thth tears tears• Calculations confirmed adequate sample sizeCalculations confirmed adequate sample size• Relevant inclusion / exclusion criteriaRelevant inclusion / exclusion criteria

Recruitment - GoodRecruitment - Good

• Sample size calculation appropriateSample size calculation appropriate

• Numbers needed to validate study achievedNumbers needed to validate study achieved

• Relevant exclusion/inclusion criteriaRelevant exclusion/inclusion criteria

RAMMbo - AllocationRAMMbo - Allocation

AllocationAllocation• Computerised randomisation and Computerised randomisation and

allocationallocation• Block size varied at random (2,4,6) to Block size varied at random (2,4,6) to

prevent prediction of which group the next prevent prediction of which group the next patient would be assigned topatient would be assigned to

• Similar baseline characteristics between Similar baseline characteristics between patients in both groupspatients in both groups

Maintenance - GoodMaintenance - Good

• Maintenance was equal for both groupsMaintenance was equal for both groups

Measurements - GoodMeasurements - Good

• All study investigators, including the All study investigators, including the statistician, were blinded, as were the statistician, were blinded, as were the women and follow-up assessment personnel women and follow-up assessment personnel

• Outcomes objective / subjectiveOutcomes objective / subjective

- Rates of flatal and faecal incontinenceRates of flatal and faecal incontinence

- Quality of life questionnaireQuality of life questionnaire

- ManometryManometry

- Anal sphincter scansAnal sphincter scans

ConclusionConclusion

• Validity: high quality study with robust methodsValidity: high quality study with robust methods

• Randomised, computerised allocation with Randomised, computerised allocation with appropriate blindingappropriate blinding

• Appropriate sample size calculationAppropriate sample size calculation

• Good follow up rates for quality of life Good follow up rates for quality of life questionnaire >80%, anal ultrasound and questionnaire >80%, anal ultrasound and manometry less complete at +- 50%manometry less complete at +- 50%

• Grade 1 evidence for the use of end-to-end Grade 1 evidence for the use of end-to-end repairrepair

DiscussionDiscussion

• This study’s evidence conflicts with This study’s evidence conflicts with previous studies that have changed previous studies that have changed our practiceour practice

• This RCT supports the end-to-end This RCT supports the end-to-end technique, particularly if dissection of technique, particularly if dissection of the external anal sphincter is neededthe external anal sphincter is needed