• Robin D Blok, Sarah Sharabiany, Jaap Stoker, Ellen T M Laan, BoskerRobbert J IRJIDepartment Surgery, Deventer Hospital, Deventer, the Netherlands., BurgerJacobus W AJWADepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Sanjay Chaudhri, Peter van Duijvendijk, Boudewijn van Etten, van GelovenAnna A WAAWDepartment of Surgery, Tergooi Hospital, Hilversum, the Netherlands., de GraafEelco J REJRDepartment of Surgery, IJsselland Hospital, Capelle aan de IJssel, the Netherlands., Christiaan Hoff, Roel Hompes, LeijtensJeroen W AJWADepartment of Surgery, St. Laurentius Hospital, Roermond, the Netherlands., Joost Rothbarth, RuttenHarm J THJTDepartment of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Baljit Singh, VuylstekeRonald J C L MRJCLMDepartment of Surgery, Spaarne Gasthuis, Haarlem, the Netherlands., de WiltJohannes H WJHWDepartment of Surgery, Radboud University Medical Center, Nijmegen, the Netherlands., DijkgraafMarcel G WMGWDepartment of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Willem A Bemelman, Gijsbert D Musters, and Pieter J Tanis.
• Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
• Ann. Surg. 2022 Jan 1; 275 (1): e37e44e37-e44.

ObjectiveTo determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia.Summary Background DataBIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing).MethodsThis was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic.ResultsActuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome.ConclusionsSymptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

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