Trial of conventional suture against Duramesh: TROCAR
Research type
Research Study
Full title
A prospective single-centre double-blind randomised controlled trial of Duramesh versus conventional suture closure for laparoscopic periumbilical trocar sites
IRAS ID
350452
Contact name
Roshan Siva
Contact email
Sponsor organisation
Croydon University Hospital
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Why?
At the end of a keyhole operation, the strength-bearing layer around the abdominal muscles called "fascia", needs to be closed to prevent hernias from occurring. This is typically performed with sutures. Even when closed with sutures, the best available evidence suggests that the rate of "port-site hernia" is ~25%. The aim of this research is to investigate if a new product called "Duramesh" is better than standard suture for reducing the rate of port-site hernias after keyhole surgery.Scale of the problem:
We know that patients with hernias report discomfort and lower quality of life compared to patients without hernias. Based on NHS data (Hospital Episode Statistics), the UK performs around 1.5 million keyhole operations per year. Therefore, 375,000 people are likely to develop a port-site hernia, many of who will need another operation. It is estimated that to repair one hernia like this costs the NHS in the region of £1000. Whilst we do not know how many people with a port-site hernia require an operation, it does appear to be an overlooked and costly problem that could be prevented.What?
Duramesh is a ribbon of mesh attached to the end of a needle. Its 3D shape is that of a hollow cylinder, like the outer sheath of a cable without the inner electrical wires. Duramesh is used just like a normal suture, except after stitching and tying, it flattens out becoming a strip of mesh to reinforce the wound.Who?
This trial will be performed on patients who are undergoing keyhole surgery in the NHS. Half of patients will receive Duramesh (intervention group), and half will receive standard suture (control group). Patients will be randomly allocated to one of the groups and will not know which closure technique they will receive.Where?
This trial will be conducted at Croydon University Hospital.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0057
Date of REC Opinion
10 Apr 2025
REC opinion
Further Information Favourable Opinion