NCT05163873Completed
ExPECT: Extraperitoneal End Colostomy Trial
ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase
Source: ClinicalTrials.gov · Last updated 18 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 8 Nov 2021
- Start date
- 9 Dec 2021
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Swansea Bay University Health Board
- Diseases
- Colorectal cancer
- NCT number
- NCT05163873
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 9 Dec 2021 to the primary completion date, 31 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having emergency surgery
- Previous or current abdominal wall stoma
- Previous incisional hernia repair with disruption of abdominal wall layers
Other
- Lacking the capacity to consent
- Intention to form loop colostomy, ileostomy or double-barrelled stoma
- Pregnant or breastfeeding (as determined by standard NHS procedures)
Who the study is looking for
- Aged 18 years and over
- Able and willing to give informed consent to participate
- Elective patient for colorectal surgery requiring formation of permanent end colostomy (This may include patients undergoing surgery for rectal or anal cancer, inflammatory bowel disease, diverticular disease and functional bowel disorders)
- Suitable to receive both trans-peritoneal and extra-peritoneal techniques
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiff and Vale University Health Board Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Aneurin Bevan University Health Board Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Swansea Bay University Health Board Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.