1. Repair of obstetric anal sphincter tears Journal Club 18 th February 2011 By Dr. Ian Haines GP-ST1 & Nevine te West

2. Introduction: Obstetric anal sphincter tears FIRST degree FIRST degree SECOND degree SECOND degree

3. Introduction: Obstetric anal sphincter tears THIRD & FOURTH degree THIRD & FOURTH degree

4. Introduction Repair of obstetric anal sphincter tears does not give optimal results Repair of obstetric anal sphincter tears does not give optimal results Which kind of repair is superior is an ongoing debate: end-to-end versus overlapping Which kind of repair is superior is an ongoing debate: end-to-end versus overlapping Previous RCT by Sultan changed our practice as the overlapping technique was found to give better results in anatomical structure, function and symptoms Previous RCT by Sultan changed our practice as the overlapping technique was found to give better results in anatomical structure, function and symptoms This paper shows opposite results to those of Sultan This paper shows opposite results to those of Sultan

5. Aims and Objectives Aim: evaluation of results of overlapping technique versus end-to-end in repairing 3 rd degree obstetric anal sphincter tears evaluation of results of overlapping technique versus end-to-end in repairing 3 rd degree obstetric anal sphincter tears Objective: appraise paper appraise paper determine validity of the paper, identify if the results are reliable enough to help answer the question and subsequently change clinical practice determine validity of the paper, identify if the results are reliable enough to help answer the question and subsequently change clinical practice gain experience in critical appraisal of evidence gain experience in critical appraisal of evidence

6. The Clinical Question: In women with obstetric anal sphincter tears, is overlapping or end to end technique more superior? Population: women with obstetric anal sphincter tears Intervention: end-to-end technique Comparison: overlapping Outcome: flatal and faecal incontinence, integrity of anal sphincter on scan and its function by manometry

7. Previous Review – Cochrane review 2010 - 3 eligible trials Overlap associated with lower risk faecal urgency & anal incontinence Overlap associated with lower risk faecal urgency & anal incontinenceBUT Heterogeneity of studies Heterogeneity of studies Variation of the outcome measures Variation of the outcome measures Experience surgeons not addressed Experience surgeons not addressed Primiparous and multiparous included Primiparous and multiparous included Authors couldn’t recommend technique Authors couldn’t recommend technique

8. Paper appraised Overlapping Compared With End-to-End Repair of Third- and Fourth-Degree Obstetric Anal Sphincter Tears – Overlapping Compared With End-to-End Repair of Third- and Fourth-Degree Obstetric Anal Sphincter Tears – A Randomised Controlled Trial Obstetrics and Gynaecology Vol. 116, no. 1, 16- 24 July 2010 Obstetrics and Gynaecology Vol. 116, no. 1, 16- 24 July 2010 Scott A. Farrell, MD, Donna Gilmour, MD, Geoffrey K. Turnbull, MD, Matthias H. Schmidt, MD, Thomas F. Baskett, MD, Gordon Flowerdew, PhD, and Cora A. Fanning, BN Scott A. Farrell, MD, Donna Gilmour, MD, Geoffrey K. Turnbull, MD, Matthias H. Schmidt, MD, Thomas F. Baskett, MD, Gordon Flowerdew, PhD, and Cora A. Fanning, BN

9. Study Design Randomised controlled trial Randomised controlled trial Chose to appraise this article on request of Mr Parsons as a randomised controlled trial and different conclusion to previous studies on suturing of 3 rd degree tears Chose to appraise this article on request of Mr Parsons as a randomised controlled trial and different conclusion to previous studies on suturing of 3 rd degree tears

10. Methods -1 Randomised controlled trial comparing overlapping to end-to-end Randomised controlled trial comparing overlapping to end-to-end Appropriate sample size calculation Appropriate sample size calculation Only primiparous women included with total 3 rd degree or 4 th degree tears Only primiparous women included with total 3 rd degree or 4 th degree tears Computerised randomisation & allocation Computerised randomisation & allocation Study investigators, statistician, patients and follow up investigators blinded Study investigators, statistician, patients and follow up investigators blinded

11. Methods -2 Protocol approved by health care centre board Protocol approved by health care centre board Women consented on 2 occasions Women consented on 2 occasions Primary outcome: flatal incontinence at 6/12 Primary outcome: flatal incontinence at 6/12 Secondary outcome: faecal incontinence, quality-of-life scores, anal ultrasound for internal & external anal sphincter integrity, anal manometry for anal sphincter function Secondary outcome: faecal incontinence, quality-of-life scores, anal ultrasound for internal & external anal sphincter integrity, anal manometry for anal sphincter function

12. Flow chart of study

13. Results 149 primiparous women: 75 end-to-end & 74 overlapping with similar baseline characteristics 149 primiparous women: 75 end-to-end & 74 overlapping with similar baseline characteristics - Overlapping > 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 15% vs 8% not (significant) - Internal & external sphincter defects not significantly different - Anal sphincter function with manometry not significantly different

14. GATE Frame Outcome Faecal incontinence End-to-end (75) Overlapping (74) Intervention Comparison Participants Source population Primiparous women with 3 rd or 4 th degree tears Present Absent Eligible population 671 Participants 149 (25) 5 (8%) (92%) 9 ( 15%) (85%)

15. Author’s conclusion End-to-end lower rates anal incontinence End-to-end lower rates anal incontinence Advise end-to-end technique Advise end-to-end technique Possibility greater denervation & scarring of eas during dissection for overlap repair Possibility greater denervation & scarring of eas during dissection for overlap repair Advantages of their study: Advantages of their study: - Only primparous women - Only complete eas tears - Clear objectives & measures of outcome Disadvantages: Disadvantages: - ? Validated questionnaires (not mentioned) - Surgeon’s experience greater in end-to-end group

16. Critical Appraisal GATE Frame GATE Frame RAMMBO RAMMBO

17. RAMMbo RAMMbo is the acronym used to appraise studies: o Recruitment o Allocation o Maintenance o Measurements blinded blinded objective objective

18. RAMMbo - Recruitment Were the subjects representative of the target population? Yes, all subjects experienced 3 rd or 4 th tears Yes, all subjects experienced 3 rd or 4 th tears Calculations confirmed adequate sample size Calculations confirmed adequate sample size Relevant inclusion / exclusion criteria Relevant inclusion / exclusion criteria

19. Recruitment - Good Sample size calculation appropriate Sample size calculation appropriate Numbers needed to validate study achieved Numbers needed to validate study achieved Relevant exclusion/inclusion criteria Relevant exclusion/inclusion criteria

20. RAMMbo - Allocation Allocation Computerised randomisation and allocation Computerised randomisation and allocation Block size varied at random (2,4,6) to prevent prediction of which group the next patient would be assigned to Block size varied at random (2,4,6) to prevent prediction of which group the next patient would be assigned to Similar baseline characteristics between patients in both groups Similar baseline characteristics between patients in both groups

21. Maintenance - Good Maintenance was equal for both groups Maintenance was equal for both groups

22. Measurements - Good All study investigators, including the statistician, were blinded, as were the women and follow-up assessment personnel All study investigators, including the statistician, were blinded, as were the women and follow-up assessment personnel Outcomes objective / subjective Outcomes objective / subjective - Rates of flatal and faecal incontinence - Quality of life questionnaire - Manometry - Anal sphincter scans

23. Conclusion Validity: high quality study with robust methods Validity: high quality study with robust methods Randomised, computerised allocation with appropriate blinding Randomised, computerised allocation with appropriate blinding Appropriate sample size calculation Appropriate sample size calculation Good follow up rates for quality of life questionnaire >80%, anal ultrasound and manometry less complete at +- 50% Good follow up rates for quality of life questionnaire >80%, anal ultrasound and manometry less complete at +- 50% Grade 1 evidence for the use of end-to-end repair Grade 1 evidence for the use of end-to-end repair

24. Discussion This study’s evidence conflicts with previous studies that have changed our practice This study’s evidence conflicts with previous studies that have changed our practice This RCT supports the end-to-end technique, particularly if dissection of the external anal sphincter is needed This RCT supports the end-to-end technique, particularly if dissection of the external anal sphincter is needed