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OUTCOMES OF END TO END VERSUS OVERLAPPING TECHNIQUES OF REPAIR OF CHRONIC OBSTETRIC ANAL SPHINCTER INJURY: A RANDOMIZED CONTROLLED TRIAL
Introduction: In Uganda, 1 in every 1000 women who are having a vaginal birth are at risk of sustaining Obstetric Anal Sphincter Injuries (OASIs). There are two known surgical techniques of repair of OASIs; end to end and overlapping. There is a knowledge gap on which method of repair of chronic OASIs has better outcomes. This randomized controlled trial compared the outcomes of end to end versus overlapping techniques of repair of chronic OASIs. The primary objective of this study was to compare the proportion of women with flatal-faecal incontinence 3 months post repair. Methods: This was a non-inferiority Randomised Controlled Trial conducted in the Uro-gynaecology department of Mulago National Referral Hospital. The sample size was 104 with each arm having 52 participants. The primary outcome was the proportion of women with flatal-faecal incontinence 3 months post repair while the secondary outcomes were; wound breakdown, perineal pain, blood loss and duration of surgery. Data was entered into STATA version 13.0 software for analysis. The primary outcome was evaluated using Per Protocol (PP) and Intention to Treat (ITT) analysis. A P-value of less than 0.05 was considered significant. Results: Of the 104 participants randomised, 98 returned for follow up. Analysis by Per protocol found the proportion of participants who developed flatal-faecal incontinence in the end to end arm was 1/48 (2.08%) and 1/50 (2.00%) in the overlapping arm (Risk Ratio 1.04, Confidence Interval 0.06-15.77 and P-value 0.136). Analysis by Intention to treat found the proportion of participants with flatal-faecal incontinence was 1/52 in the end to end arm and 1/52 in the overlapping arm (Risk Ratio 1.00, Confidence interval 0.08-16.00 and P-value 0.258). Conclusions and recommendations: This study found that there was no statistically significant difference in flatal-faecal incontinence, perineal pain and wound breakdown between end to end and overlapping techniques of repair of chronic OASIs. Mean intraoperative blood loss was less in the end to end arm as compared to the overlapping arm. The end to end technique of repair is therefore less inferior to the overlapping technique hence surgeons are encouraged to use the end to end technique.
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