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Duramesh™ versus sutura convencional para la prevención de hernias en el sitio de trócar tras cirugía laparoscópica
Lawrence Nip1,2, Sarah Zhao3,4, Rhys Thomas3
1The Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK. lscnip@doctors.org.uk.
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.
