Status:
COMPLETED
Reinforcement of Closure of Stoma Site
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
LifeCell
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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®) i...
Detailed Description
Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Use of biological meshes in these situations may provide a saf...
Eligibility Criteria
Inclusion
- Require an elective closure of an ileostomy or a colostomy.
- Able and willing to provide written informed consent.
- Aged 18 years or over.
Exclusion
- Taking part in another clinical study which is related to the surgical procedure.
- Allergic to any porcine or collagen products.
- History of familial adenomatous polyposis, due to increased risk of desmoid tumours.
- The surgeon determines that a mesh repair will definitely be required e.g. due to large parastomal hernia.
- Unable or unwilling to provide written informed consent.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2018
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT02238964
Start Date
November 1 2012
End Date
May 18 2018
Last Update
October 11 2018
Active Locations (35)
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1
Hvidovre Hospital
Copenhagen, Denmark
2
Academisch Medisch Centrum
Amsterdam, Netherlands
3
Tameside General Hospital
Ashton-under-Lyne, United Kingdom
4
Royal United Hospital Bath
Bath, United Kingdom