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Duramesh™ versus conventional suture for prevention of trocar-site hernia following laparoscopic surgery (TROCAR): study protocol for a double-blind randomised controlled trial
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Duramesh™ versus conventional suture for prevention of trocar-site hernia following laparoscopic surgery (TROCAR): study protocol for a double-blind randomised controlled trial
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Duramesh™ versus conventional suture for prevention of trocar-site hernia following laparoscopic surgery (TROCAR): study protocol for a double-blind randomised controlled trial
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Journal Article
Duramesh™ versus conventional suture for prevention of trocar-site hernia following laparoscopic surgery (TROCAR): study protocol for a double-blind randomised controlled trial
2025
Overview
Background
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.
Methods
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.
Conclusion
TROCAR will provide level 1 evidence on trocar-site hernia prevention in both the emergency and elective settings.
Trial registration
Registration number ISRCTN14473961 (
https://doi.org/10.1186/ISRCTN14473961
). Registered on 14th April 2025.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
Subject
/ Duramesh
/ Hernia
/ Hernias
/ Humans
/ Incisional Hernia - diagnostic imaging
/ Incisional Hernia - etiology
/ Incisional Hernia - prevention & control
/ Laparoscopy - adverse effects
/ Laparoscopy - instrumentation
/ Medicine
/ Randomized Controlled Trials as Topic
/ Skin
/ Statistics for Life Sciences
/ Surgeons
/ Surgical Instruments - adverse effects
/ Suture Techniques - adverse effects
/ Suture Techniques - instrumentation
/ Suture Techniques - mortality
/ Sutures
