Duramesh versus suture for prevention of port-site hernia after keyhole surgery
| ISRCTN | ISRCTN14473961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14473961 |
| IRAS number | 350452 |
| Secondary identifying numbers | CPMS 65163 |
- Submission date
- 10/04/2025
- Registration date
- 14/04/2025
- Last edited
- 14/04/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
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%. This research aims to investigate if a new product called "Duramesh" is better than standard suture for reducing the rate of port-site hernia after keyhole surgery.
Who can participate?
Adult patients who are undergoing keyhole surgery in the NHS.
What does the study involve?
Half of the 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. People measuring the outcome are also blinded to which treatment participants receive (double-blind). Other than the closure method, the operation that participants receive will not be any different from if they were not part of this trial. Participants will be followed up after their keyhole operation at 3 months, 1 year and 2 years. At each of the timepoints, an ultrasound scan of the umbilical region will be performed to look for port-site hernia. Other outcome measures include wound events, re-operation, length of hospital stay and postoperative quality of life.
What are the possible benefits and risks of participating?
In terms of benefit, Duramesh may reduce patients’ risk of developing a port-site hernia within 2 years and possibly beyond that timeframe, too. This may prevent patients from requiring another operation in the future, some of which may be an emergency with incarcerated or strangulated bowel. In terms of possible risk, Duramesh is non-absorbable, similar to most modern synthetic hernia meshes. It will therefore remain intact for the rest of the patient's life. It is not known how this affects a patient's chance of getting complications, but the type of complications is similar to standard surgical suture. Having Duramesh does not affect a patient's ability to have surgery in the future.
Where is the study run from?
Croydon University Hospital, London, UK.
When is the study starting and how long is it expected to run for?
October 2024 to November 2028. The study will start recruiting in May 2025. It is expected to run for 3.5 years in total: 1.5 years for recruitment and 2 years for follow-up.
Who is funding the study?
Eurosurgical Ltd.
Who is the main contact?
TROCAR trial coordinator, ch-tr.trocartrial@nhs.net
Contact information
Principal Investigator
Croydon University Hospital, 530 London Road, Thornton Heath
London
CR7 7YE
United Kingdom
 ORCID ID |
0000-0002-3710-9953 |
|---|---|
| Phone | +44 (0)7784378695 |
| samgparker@nhs.net |
Public, Scientific
Trial coordinator, Croydon University Hospital, 530 London Road, Thornton Heath
London
CR7 7YE
United Kingdom
| ORCID ID |
0000-0001-5816-7151 |
|---|---|
| Phone | +44 (0)7840059436 |
| l.nip@nhs.net |
Study information
| Study design | Single-centre parallel-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective single-centre double-blind randomised controlled trial of Duramesh versus conventional suture closure for laparoscopic periumbilical trocar sites |
| Study acronym | TROCAR |
| Study hypothesis | The principal aim is to determine if Duramesh is superior to standard suture closure for reducing rates of trocar-site hernia following laparoscopic surgery. |
| Ethics approval(s) |
Approved 10/04/2025, East of England, Cambridge Central REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048089; cambridgecentral.rec@hra.nhs.uk), ref: 25/EE/0057 |
| Condition | Duramesh versus conventional suture closure for laparoscopic periumbilical trocar sites |
| Intervention | TROCAR is a single-centre, parallel arm, randomised controlled trial of Duramesh versus conventional suture, with blinding of patients and outcome assessors at primary outcome assessment. The aim is to establish if Duramesh is superior to conventional suture for the prevention of trocar-site hernia at 2 years when closing periumbilical trocar sites greater than or equal to 10mm. A total of 250 participants undergoing laparoscopic surgery will be randomly allocated (randomisation ratio 1:1 and computer-generated sequence block size 4) to one of the two groups and followed up for 2 years. Patients will attend follow-up appointments at Croydon University Hospital at 3 months, 1 year and 2 years after the index operation. The primary outcome is the cumulative incidence of trocar-site hernia at 2 years. Secondary outcomes include 90-day occurrence of wound events, reoperation, and mortality, and patient-reported quality of life at 3 months, 1 year and 2 years. An ultrasound scan of the periumbilical region will be performed to look for trocar-site hernia at each of the timepoints. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The cumulative occurrence of trocar-site hernia over 2 years, measured using ultrasound scan at 3 months, 1 year and 2 years |
| Secondary outcome measures | 1. Surgical site occurrence within 90 days measured using physical examination 2. Reoperation within 90 days measured using data collected from patient medical records at one timepoint 3. Mortality within 90 days measured using data collected from patient medical records at one timepoint 4. Length of hospital stay in days measured using data collected from patient medical records at one timepoint 5. Patient reported quality of life (QoL) measured using the Modified EuraHS-QoL score and Modified Carolinas Comfort Scale at 3 months, 1 year and 2 years |
| Overall study start date | 01/10/2024 |
| Overall study end date | 01/11/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Participant inclusion criteria | 1. 18 years or older. 2. Able to provide written informed consent to participation, without barriers that might prevent follow-up. 3. Any laparoscopic procedure pertaining to the domain of general surgery, requiring periumbilical incision at the linea alba for trocar insertion 10mm or greater. 4. Extraction sites acceptable up to a maximum of 3cm. 5. Concurrent umbilical hernia if camera port inserted through the defect with subsequent primary repair without planar mesh. 6. Hernia at a remote site from port incisions e.g. concurrent inguinal hernia. 7. Previous abdominal surgery, except for the condition specified in exclusion criteria below. |
| Participant exclusion criteria | 1. Lack of capacity to consent to trial participation. 2. Procedures where placement of a periumbilical trocar <10mm is planned. 3. Periumbilical trocar insertion not planned or not possible. 4. Laparoscopic gynaecological procedures. 5. Laparoscopic urological procedures. 6. Single-incision laparoscopic surgery. 7. Unanticipated conversion to laparotomy or specimen extraction site at the umbilicus exceeds 3cm. 8. Use of planar mesh or previous planar mesh covering the periumbilical trocar site. 9. Concurrent umbilical hernia not primarily repaired during trial procedure. 10. Previous abdominal surgery, if in the opinion of the principal investigator, is not suitable for inclusion e.g. battlefield abdomen, enterocutaneous fistulae, multiple previous laparotomies etc. 11. Pregnancy. 12. BMI > 40. |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 01/11/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Croydon
CR7 7YE
United Kingdom
Sponsor information
Hospital/treatment centre
Croydon University Hospital, 530 London Road
Thornton Heath
CR7 7YE
England
United Kingdom
| Phone | +44 (0)2084013610 |
|---|---|
| michael.chang@nhs.net | |
| Website | https://www.croydonhealthservices.nhs.uk/ |
"ROR" |
https://ror.org/00sh7p618 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | During the study, research data will not be publicly available and will be stored on Project REDCap hosted by University College London. Upon the end of the study, the full dataset from the REDCap system will be transferred to University College London's Data Safe Haven for archiving. Data will not be made available for sharing until after the publication of the main results of the study. Contact the TROCAR trial coordinator, ch-tr.trocartrial@nhs.net. Thereafter, pseudonymised patient data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed study has been given a favourable opinion by a Research Ethics Committee. |
Editorial Notes
10/04/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
