Duramesh™ versus conventional suture for prevention of trocar-site hernia following laparoscopic surgery (TROCAR): study protocol for a double-blind randomised controlled trial.

Abstract

<h4>Background</h4>Trocar-site hernia is an underappreciated condition with estimates of approximately 25% at 2 years follow-up. Duramesh™ has emerged as a novel product with potential benefits for incisional hernia prevention. The aim of this trial is to establish if Duramesh is superior to conventional suture for prevention of periumbilical trocar-site hernia following laparoscopic surgery.<h4>Methods</h4>The TROCAR trial is a prospective single-centre, parallel arm, double-blind randomised controlled trial conducted in the United Kingdom. A total of 250 randomised participants (1:1 ratio) will be allocated to receive either Duramesh or conventional suture (J-vicryl or J-PDS). The primary outcome is the cumulative incidence of sonographically detected periumbilical trocar-site hernia at 2 years of the index operation. Secondary outcomes are 90-day surgical site occurrence (SSO), 90-day surgical site infection (SSI), 90-day rate of reoperation, 90-day mortality, length of hospital stay, and quality of life at 3 months, 1 year and 2 years measured using a modified EuraHS-QoL score and modified Carolinas Comfort Scale.<h4>Conclusion</h4>TROCAR will provide level 1 evidence on trocar-site hernia prevention in both the emergency and elective settings.<h4>Trial registration</h4>Registration number ISRCTN14473961 ( https://doi.org/10.1186/ISRCTN14473961 ). Registered on 14th April 2025.