Women’s Health
The effectiveness of perineorrhaphy during vaginal pelvic organ prolapse surgery to reduce the risk of reoperation Beth MacLean* Beth MacLean MacLean MacLean MacLean MacLean Perinatal and Cardiovascular Epidemiology, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden
Background: In the US alone, at least 140,000 women undergo pelvic organ prolapse surgery annually. Reconstruction of the perineal body between the anus and vagina through concomitant perineorrhaphy is frequently performed, despite uncertain benefit.
Methods: In a pre-registered observational registry-based cohort study, we sought to emulate a pragmatic target trial where patients undergoing pelvic organ prolapse surgery were perioperatively randomized to perineorrhaphy or not if the clinical relevance of performing the procedure was uncertain. Eligible patients were identified from the comprehensive Swedish National Quality Register of Gynecological Surgery, whereby they received primary vaginal pelvic organ prolapse surgery with native tissue repair between January 1st 2007 to June 30th 2021. The primary outcome was absolute cumulative risk difference in reoperation by 5 years, estimated as the average treatment effect following Stürmer trimming to exclude patients less likely to be included in a trial. Secondary patient-reported outcomes included subjective recurrence (feeling a vaginal bulge) or dissatisfaction with results by 1 year. Missing data were addressed through multiple imputations by chained equations and outcome estimates were pooled from 20 imputed datasets.
Results: In total, 40,607 eligible patients (10,634 [26.2%] with perineorrhaphy) were included, of which 21,206 patients contributed data to the target trial emulations. The estimated risk of reoperation per 100 patients was 11.5 (95%CI 10.5; 12.6) following surgery with perineorrhaphy and 13.5 (95%CI 12.9;14.1) without, equating to an absolute risk reduction of 2.0 reoperations per 100 patients (95%CI -3.2; -0.8). Perineorrhaphy also improved patient-reported secondary outcomes.
Conclusion: Among patients with uncertain benefit of having a perineorrhaphy during pelvic organ prolapse surgery, this additional procedure reduced the risk of reoperation and improved patient-reported secondary outcomes.