Clinical trial · Interventional
ExPECT: Extraperitoneal End Colostomy Trial
ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Colostomy Stoma | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extra-peritoneal | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Trans-peritoneal
- description
- Surgery technique in the formation of permanent end colostomy
- type
- EXPERIMENTAL
- label
- Extra-peritoneal
- description
- Surgery technique in the formation of permanent end colostomy
- interventionNames
- Procedure: Extra-peritoneal
Primary outcomes (8)
- measure
- Assessing the feasibility of the trial based on recruitment rate
- timeFrame
- Consent
- description
- number of eligible patients who consent
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Lacking the capacity to consent * Having emergency surgery * Previous or current abdominal wall stoma * Intention to form loop colostomy, ileostomy or double-barrelled stoma * Previous incisional hernia repair with disruption of abdominal wall layers * Pregnant or breastfeeding (as determined by standard NHS procedures)
References
Publications (0)
Data not yet available