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Be Part of Research - Trial Details - Reinforcement of Closure of Stoma Site
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Reinforcement of Closure of Stoma Site

Completed

Open to: ALL

Age: 18.0 - N/A

Birmingham Worcester Birmingham Chelmsford Stoke-on-Trent Yeovil Bristol Nottingham Chesterfield Macclesfield Stockton-on-Tees Wigan Bath Doncaster Leicester Margate Norwich Boston Inverness Salisbury Birmingham Coventry Great Yarmouth York Sutton in Ashfield Dorchester Ashton-under-Lyne Chertsey Chichester Harrow Walsall Wolverhampton Wythenshawe

Medical Conditions

Hernia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh (Strattice®) is superior to the standard technique in preventing herniation at 2 years.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2012 Nov 2017

Publications

"Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative. Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial. Lancet. 2020 Feb 8;395(10222):417-426. doi: 10.1016/S0140-6736(19)32637-6."; "32035551"; "Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative. Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement. Colorectal Dis. 2016 Sep;18(9):889-96. doi: 10.1111/codi.13310."; "26924621"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.

Intervention Arm Group : Strattice™ Reconstructive Tissue Matrix;

Intervention Type : PROCEDURE
Intervention Description : The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.

Intervention Arm Group : Standard closure;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital
    Birmingham
  • Worcestershire Royal Hospital
    Worcester
  • Sandwell General Hospital
    Birmingham
  • Broomfield Hospital
    Chelmsford
  • Royal Stoke University Hospital
    Stoke-on-Trent
  • Yeovil District Hospital
    Yeovil
  • Bristol Royal Infirmary
    Bristol
  • Queens Medical Centre
    Nottingham
  • Chesterfield Royal Hospital
    Chesterfield
  • Macclesfield District General Hospital
    Macclesfield
  • University Hospital Of North Tees
    Stockton-on-Tees
  • Royal Albert Edward Infirmary
    Wigan
  • Royal United Hospital Bath
    Bath
  • Doncaster Royal Infirmary
    Doncaster
  • University Hospitals of Leicester NHS Trust
    Leicester
  • Queen Elizabeth The Queen Mother Hospital
    Margate
  • Norfolk & Norwich University Hospital
    Norwich
  • Pilgrim Hospital
    Boston
  • Raigmore Hospital
    Inverness
  • Salisbury District Hospital
    Salisbury
  • Heart of England NHS Foundation Trust
    Birmingham
  • University Hospital Coventry
    Coventry
  • James Paget University Hospital
    Great Yarmouth
  • York Hospital
    York
  • Kings Mill Hospital
    Sutton in Ashfield
  • Dorset Country Hospital
    Dorchester
  • Tameside General Hospital
    Ashton-under-Lyne
  • St Peters Hospital
    Chertsey
  • Western Sussex Hospitals NHS Foundation Trust
    Chichester
  • St Marks Hospital
    Harrow
  • Manor Hospital
    Walsall
  • New Cross Hosptial
    Wolverhampton
  • Wythenshawe Hosptial
    Wythenshawe


The study is sponsored by University of Birmingham and is in collaboration with LifeCell.



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Read full details for Trial ID: NCT02238964
Last updated 10 October 2018

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