Evidence map›Paper›PMID 41466434›Full record

ArticleTrials2025

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

Lawrence Nip, Sarah Zhao, Rhys Thomas, Paul Bassett, David Ross, Alastair C J Windsor, Chris Brew-Graves, Steve Halligan, Samuel G Parker, the TROCAR Trial Management Group

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Lawrence NipThe Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK. lscnip@doctors.org.uk.ORCID http://orcid.org/0000-0001-5816-7151
Sarah ZhaoThe Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK.
Rhys ThomasThe Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK.
Paul BassettStatsconsultancy Ltd, 40 Longwood Lane, Amersham, Buckinghamshire, HP7 9EN, UK.
David RossThe London Clinic, 20 Devonshire Place, London, W1G 6BW, UK.
Alastair C J WindsorThe Princess Grace Hospital, 42-52 Nottingham Place, London, W1U 5NY, UK.
Chris Brew-GravesDivision of Medicine, Centre for Medical Imaging, The Rayne Institute, University College London, 5 University Street, London, WC1E 6JF, UK.
Steve HalliganDivision of Medicine, Centre for Medical Imaging, The Rayne Institute, University College London, 5 University Street, London, WC1E 6JF, UK.
Samuel G ParkerThe Abdominal Wall Unit, Croydon University Hospital, 530 London Road, Thornton Heath, London, CR7 7YE, UK.
the TROCAR Trial Management Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrocar-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.

methodsThe 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.

conclusionTROCAR will provide level 1 evidence on trocar-site hernia prevention in both the emergency and elective settings.

trial registrationRegistration number ISRCTN14473961 ( https://doi.org/10.1186/ISRCTN14473961 ). Registered on 14th April 2025.

Indexed as

Incisional HerniaLaparoscopySurgical InstrumentsSuturesSuture TechniquesDouble-Blind MethodHumansLength of StayProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSurgical Wound InfectionTime FactorsTreatment OutcomeUnited KingdomDurameshHernia preventionLaparoscopic surgeryMesh sutureTrocar-site hernia

Identifiers

PMID41466434
PMCPMC12829174

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.