Reinforcement of closure of stoma site using a biological mesh

Not Applicable

Completed

• Conditions: Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Surgery; Surgery

• Registration Number: ISRCTN46330337
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2016 feasibility study results in: https://www.ncbi.nlm.nih.gov/pubmed/26924621 (added 10/04/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/32035551/ (added 24/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-30
• Study Completion: 2018-08-01
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 790

Inclusion Criteria

Patients to be included in the study must:
1. Require an elective closure of stoma site
2. Have given written informed consent
3. Male & Female, aged 18 or over
4. Agree to the randomised procedure

Exclusion Criteria

1. Patients taking part in another clinical study which directly relates to the surgical procedure
2. Allergic to any porcine or collagen products
3. Unable or unwilling to provide written informed consent

Added 03/06/2015:
4. History of familial adenomatous polyposis, due to increased risk of desmoid tumours
5. The surgeon determines that a mesh repair will definitely be required e.g. due to large parastomal hernia

Study & Design

• Study Type: Interventional
• Study Design: Not specified