Abstract
BACKGROUND: Mesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet current evidence remains limited for smaller umbilical hernias. Important questions concern optimal mesh positioning and wound complications/surgical-site occurrences. The aim of this study was to report the preliminary results of a trial investigating surgical-site occurrences in suture versus mesh repair for umbilical hernias less than or equal to 2 cm. METHODS: A randomized, controlled, parallel-group, double-blind, multicentre trial across six Swedish surgical units is comparing 4 × 4 cm macroporous lightweight onlay mesh repair with conventional suture repair for primary elective umbilical hernias less than or equal to 2 cm. Intraoperative centralized web-based randomization ensured allocation concealment. The primary outcome of the trial is recurrence at 3 years, whereas secondary outcomes (the focus of this study) include surgical-site occurrences and pain intensity at 30 days post-surgery. RESULTS: From February 2020 to January 2024, 290 participants were randomly assigned to either suture or mesh repair. After exclusion and loss to follow-up, the remaining population for analysis was 144 participants for suture repair and 135 participants for mesh repair. Surgical-site occurrences (Clavien-Dindo grade greater than or equal to I) affected 32 mesh repair participants (23.7%) compared with 26 suture repair participants (18.1%), without any significant increase in surgical-site occurrences for mesh repair (OR 1.39 (95% c.i. 0.78 to 2.51)). Clinically relevant surgical-site occurrences (Clavien-Dindo grade greater than or equal to II) were less common in the mesh group (2 participants; 1.5%) compared with the suture group (4 participants; 2.8%). The median duration of surgery was 32 min for suture repair and 45 min for mesh repair (P < 0.001). Assessment of pain intensity revealed that 82.0% of suture repair participants and 73.0% of mesh repair participants reported no pain (P = 0.061). CONCLUSION: This randomized clinical trial provides high-level evidence for mesh repair for umbilical hernias less than or equal to 2 cm. With regard to early postoperative outcomes, such as surgical-site occurrences, onlay mesh repair can be considered comparable to suture repair and is safe to use for smaller umbilical hernias. REGISTRATION NUMBER: NCT04231071 (http://www.clinicaltrials.gov).