A Modern Comparison of Suture Repair versus Mesh Repair for Incisional Hernia: A Study Protocol for a Randomized Controlled Trial

Background : The utilization of mesh is considered the standard of care for incisional hernia repairs to reduce recurrence. However, mesh complications – including infection and enterocutaneous fistulae – can impact patients’ quality of life and culminate in reoperation. Meanwhile, techniques for fascial closure and our understanding of abdominal wall tension physiology have improved since the original studies comparing suture and mesh-based ventral hernia repairs were published, but there have been no contemporary trials comparing these approaches since the evolution of fascial closure techniques. Methods : This is a registry-based, multicenter, patient-blinded randomized controlled trial designed to investigate whether a suture-only technique utilizing a posterior rectus sheath release, small bite technique and 4:1 closure is noninferior to a retrorectus mesh-based repair for clean, incisional hernias that are 2-6cm in width. The primary study endpoint is abdominal wall-specific quality of life (HerQLes) at one year postoperatively. Our primary hypothesis is that suture-based incisional hernia repair will be non-inferior to mesh-based repairs with respect to HerQLes summary score at one-year postoperatively. Secondary outcomes of interest include hernia recurrence at 1, 2, and 5-years postoperatively, pain as measured by the PROMIS-3a Pain Intensity survey, cost-effectiveness ratios, 30-day readmissions, wound complications, and reoperations. Additional outcomes include hernia recurrence, patient-reported quality of life, wound complications, hernia-related reoperation at 30-days, 1-year, 2-years, and 5-years. Discussion : The risks of mesh-related complications, coupled with the lack of contemporary data, warrant new investigation into the necessity of mesh placement for all incisional hernias. Trial registration : NCT05599750. Registered on October 26, 2022.