Surgery · Medical Literature
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.
Abstract
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).
Clinical relevance
Small ventral hernia repair is one of the most frequently performed general surgical procedures, yet surgical site occurrences (SSOs) remain a significant source of morbidity, readmission, and patient dissatisfaction despite routine planar polypropylene mesh use. This trial addresses a critical evidence gap by evaluating whether a novel mesh-suture device — which integrates mesh reinforcement with suture-like implantation to minimize subcutaneous dissection and tissue trauma — can reduce wound morbidity compared to standard planar mesh. Surgeons performing ventral hernia repairs should follow this trial closely, as its results may directly inform device selection and operative technique standards.
Key findings
1. Study design: Prospective, parallel-group, patient- and assessor-blinded, randomized controlled superiority trial conducted across multiple Danish regional hospitals, with 1:1 randomization to mesh-suture vs. planar polypropylene mesh. 2. Primary endpoint: Surgical site occurrence (SSO) rate, chosen to capture the most clinically relevant wound morbidity outcome in this patient population. 3. Secondary endpoints include operative time, long-term hernia recurrence, reoperation rates, and patient-reported quality of life measured via validated instruments (EQ-5D-5L and Abdominal Hernia Q). 4. Socio-economic outcomes — including return to work and primary care/family physician contact rates — are formally incorporated as secondary endpoints, broadening the evaluation beyond purely clinical metrics. 5. Analysis will follow the intention-to-treat principle, ensuring methodological rigor and minimizing bias in outcome interpretation. 6. NOTE: As this is a published protocol article rather than a results paper, no effect sizes, confidence intervals, p-values, or NNT/NNH are yet available; quantitative outcome data are pending trial completion (registered ClinicalTrials.gov NCT07476560, March 16, 2026).
Practice implications
Surgeons managing elective small ventral hernias should be aware that the mesh-suture device — by design requiring less subcutaneous dissection — represents a potentially practice-changing approach to reducing SSOs, though efficacy and safety data are not yet available and adoption should await peer-reviewed results. Clinicians at institutions eligible for enrollment should consider participation in or referral to this multicenter trial, particularly for patients with elevated SSO risk profiles where wound morbidity is a primary concern. Once results are published, findings regarding operative time, recurrence, and patient-reported outcomes will provide the evidence base needed to guide evidence-based device selection in small ventral hernia repair.