Protocol for the mesh matters project: evaluating the efficacy of suture mesh vs. planar mesh in small ventral hernia repair - a randomized, blinded multicenter study.

PURPOSE: 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.

METHODS

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.

CONCLUSION

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.

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