Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh with Primary Perineal Wound Closure after Extralevator Abdominoperineal Resection (BIOPEX-study).

Abstract

OBJECTIVE\nTo determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients following extralevator abdominoperineal resection (APR) and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia.\n\n\nSUMMARY BACKGROUND DATA\nBIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing).\n\n\nMETHODS\nThis was a post-hoc 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 five years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic.\n\n\nRESULTS\nActuarial 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 seven 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.\n\n\nCONCLUSIONS\nSymptomatic perineal hernia rate at five-year follow-up after APR for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.