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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Assessing the feasibility of the trial based on recruitment rate
Timeframe: Consent
Assessing the feasibility of the trial based on data completeness
Timeframe: Week 6
Assessing the feasibility of the trial based on surgeon involvement
Timeframe: set up
Assessing the feasibility of the trial based on recruitment within sites
Timeframe: consent
Assessing the feasibility of the trial based on surgeon training
Timeframe: set up
Assessing the feasibility of the trial based on surgeon compliance with the intervention
Timeframe: month 12
Assessing the feasibility of the trial based on collection of key outcomes
Timeframe: week 6, month 6 and month 12
Assessing the feasibility of the trial based on overall QoL reported in intervention group compared with standard care group
Timeframe: week 6, month 6 and month 12