Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia...

Small ventral hernia repair is among the most performed general surgical procedures. Despite the routine use of planar polypropylene mesh, surgical site occurrences (SSO) remain a frequent cause of morbidity, readmission, and patient dissatisfaction. A novel mesh-suture integrates mesh reinforcement with suture-like implantation and may reduce subcutaneous dissection and tissue trauma. The aim of this randomized trial is to investigate differences in SSO, patient-reported outcomes (PROMs) and operation time among patients operated for small ventral hernias either with this novel mesh-suture or planar mesh as well as evaluate potential influence of mesh-suture on wider socio-economic parameters such as return to work and contact with family physician/primary sector as well as long-term occurrence.

A prospective, parallel-group, patient- and assessor-blinded, randomized controlled superiority trial conducted across Danish regional hospitals. Eligible patients undergoing elective repair of small ventral hernias are randomized 1:1 to mesh-suture or planar polypropylene mesh. The primary endpoint is SSO. Secondary endpoints include operative time, patient-reported quality of life (EQ-5D-5L, Abdominal Hernia Q), long-term recurrence, reoperation rates, and socio-economic outcomes. Analysis follows the intention-to-treat principle.

This trial evaluates whether mesh-suture reduces wound morbidity while maintaining equivalent durability. Results may inform future standards in ventral hernia repair and device selection.

The study is registered at clinicaltrials.gov om March 16th, 2026 (NCT07476560).