Abstract

Abstract Aim The aim of this study was to evaluate the safety and efficiency of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. Material & Methods Up to one third of patients experience incisional hernia after loop-ileostomy closure, justifying hernia prevention procedures. Although biological meshes have been widely used in contaminated surgical sites instead of synthetic ones due to complication concerns, previous data on the subject does not support this practice. A randomized, controlled, multi-center non-inferior feasibility trial was conducted from April 2018 – November 2021. Patients (n=102) were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene MacroTM, Medtronic) (SM) or a biological mesh (PermacolTM, Medtronic) (BM) to the retrorectus space at loop-ileostomy closure after anterior resection for rectal adenocarcinoma. The primary outcome was rate of surgical site infections (SSI) at 30-day follow-up. Results In total, 102 patients were randomized, of which 97 received the intended allocation. At 30-day follow-up, 94 patients (97%) were evaluated. Of patients in the SM group, 1/46 (2%) had SSI and in the BM group 2/48 (4%) had SSI (p>0.90). Uneventful wound healing was recorded in 38/46 (86%) and 43/48 (90%) patients in the SM and BM groups, respectively. One patient from each group underwent reoperation requiring mesh removal (p>0.90). Conclusions Both a synthetic mesh and biological mesh were safe in incisional hernia prevention after loop-ileostomy closure. Hernia prevention efficiency will be reported after long-term patient follow-ups.

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