Abstract
IMPORTANCE: Stoma reversal is associated with few complications. However, recent studies show that 1 in 3 patients develop an incisional hernia, for which half of the patients receive surgical correction. OBJECTIVE: To investigate whether prophylactic synthetic mesh placement in the retromuscular space during stoma reversal reduces the rate of stomal site incisional hernias. DESIGN, SETTING, AND PARTICIPANTS: This prospective, parallel, single-blinded randomized clinical trial was conducted between July 2018 and June 2023 and took place at 2 large teaching hospitals in the Netherlands. Data were analyzed from September 2024 and April 2025. Patients who underwent elective stoma reversal were included. Exclusion criteria included connective tissue disease, intraperitoneal dialysis, immunodeficiency, previous mesh placement within 3 cm of the stoma closure site, allergy or contraindication for mesh, pregnancy, and inflammatory bowel disease, as indication for initial stoma construction. Follow-up was at 30 days and 3, 6, 9, and 12 months postoperative. INTERVENTION: Conventional stoma closure (n = 40) vs stoma closure with preventive synthetic mesh placement in the retromuscular space (n = 39). MAIN OUTCOMES AND MEASURES: The primary outcome measure was radiological stoma site incisional hernia after 12 months. Secondary outcomes included postoperative complications, surgical site infections, and quality of life (measured by EuroQoL 5-Dimension, visual analog scale, 36-item short form survey, and hernia-related quality of life). RESULTS: A total of 88 patients were randomized to either conventional stoma closure (n = 44) or synthetic mesh-reinforced stoma closure (n = 44). At 12 months, 39 patients in the control group and 40 patients in the mesh group had completed follow-up. The rate of stoma site incisional hernia was 17.9% (n = 7) in the conventional group vs 0% (n = 0) in the mesh group (relative risk, 0.18; 95% CI, 0.034-0.330; P = .02) with a number needed to treat of 6. There was no significant difference in surgical site infections or postoperative complications. Hernia-related quality of life was significantly better at 12 months follow-up in the mesh group. CONCLUSIONS AND RELEVANCE: In this study, placement of a prophylactic synthetic mesh in the retromuscular space prevented stoma site incisional hernias. Patients receiving a synthetic mesh experienced a better hernia-related quality of life. To prevent stoma site incisional hernias, the placement of a synthetic mesh during stoma reversal should be considered. TRIAL REGISTRATION: Dutch Trial Register: NL-OMON27268.