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Abstract Introduction Mesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet evidence remains limited. An important question concerns optimal mesh positioning and surgical site occurrences (SSO). This study investigates early SSO in suture versus mesh repair for small umbilical hernias. Method A multicenter, randomized, controlled, double-blind trial across six Swedish surgical units compared a 4x4 cm lightweight onlay mesh to conventional suture repair for umbilical hernias ≤2 cm. Intraoperative centralized web-based randomization ensured allocation concealment. Participants and assessment surgeons were blinded for allocation. Primary outcome will be recurrence at 3 years. Secondary outcome was early SSO at 30 days after surgery, assessed through a physical examination and presented in this study. The trial is registered with Clinicaltrials.gov, NCT04231071. Result From February 2020 to January 2024, 290 participants were randomly assigned. After exclusion and loss to follow-up, remaining population for intention to treat analysis were n=144 (suture repair) and n=135 (mesh repair). SSO (Clavien-Dindo ≥1) were in the mesh group n=32 (24%) compared to n=26 (18%) in the suture group, without any significant increase for mesh repairs (OR 1.39, CI 0.78-2.52). BMI and defect size weren't significant risk factors. Clinically relevance SSO (Clavien-Dindo ≥2) were fewer in the mesh group n=2 (1.5%) compared to suture group n=4 (2.8%). No recurrences were detected. Discussion This randomized trial provides first high-level evidence for mesh repair in umbilical hernias ≤2 cm. Onlay mesh repair is comparable to suture repair regarding early surgical site occurrences and is safe for small umbilical hernias.
Bergström et al. (Thu,) studied this question.