Summary
Evaluating a technique to prevent parastomal hernias and improve symptoms and quality of life for those with stomas: A multi-centre feasibility randomised trial
A randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique – currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.
Contact Details
Trial Manager / Lead Contact: Kirsty Lanyon
Email: k.j.lanyon@swansea.ac.uk
Eudra CT Number: NCT05163873; IRAS ID: 291897;