ExPECT: Extraperitoneal End Colostomy Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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This feasibility study is a multi-centre, single (patient) blinded, randomised controlled trial (RCT). Co-ordination and trial management will be led from Swansea Trials Unit (STU) and we will adhere to their Standard Operating Procedures (SOPs). The study will take place across 3 sites: Swansea Bay University Health Board (SBUHB); Aneurin Bevan University Health Board and Cardiff and Vale University Health Board. Surgeons at all three sites have experience with both interventional extra-peritoneal surgical technique and the most commonly used transperitoneal technique. The investigators aim to recruit 60 participants over 12 months. Local recruitment will be co-ordinated by PIs and research teams. Recruitment is aimed to be equally distributed across all sites. Participants will be equally randomised by arm in each of the three sites: to receive the EP colostomy formation (Intervention) or the standard transperitoneal (TP) technique. Participants will remain blinded as to their treatment until the close of the study. Data collection will be performed by the Welsh Barbers trainee collaborative and the clinical and research teams, with support from PIs. Data will be stored centrally in REDCap (Research Electronic Data Capture) software. The investigators will explore whether it is possible to establish a research infrastructure in which data can be collected and co-ordinated across sites and for patients to be followed up effectively. The investigators will also look to demonstrate standardisation of the operative technique for EP stoma formation and to determine which outcome measures a future trial should explore. This feasibility trial be evaluated against specific progression criteria.

Official Title
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ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase

Conditions
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Colostomy Stoma, Cancer of Colon, Surgery, Quality of Life

Intervention / Treatment
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* Procedure: Extra-peritoneal


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Trans-peritoneal<br>Surgery technique in the formation of permanent end colostomy | |
| Experimental: Extra-peritoneal<br>Surgery technique in the formation of permanent end colostomy | Procedure: Extra-peritoneal<br>* Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported EQ5D | Quality of life measure | 1 day (At time of consent) | 
| Patient-reported EQ5D | Quality of life measure | Week 6 | 
| Patient-reported EQ5D | Quality of life measure | Week 26 | 
| Patient-reported EQ5D | Quality of life measure | Week 52 | 
| Patient-reported Colostomy Impact Score | Quality of life measure. A scoring system is in place for this measure - 0-9 indicates a minor colostomy impact, 10-38 indicates a major colostomy impact. | Week 6 | 
| Patient-reported Colostomy Impact Score | Quality of life measure. A scoring system is in place for this measure - 0-9 indicates a minor colostomy impact, 10-38 indicates a major colostomy impact. | Week 26 | 
| Patient-reported Colostomy Impact Score | Quality of life measure. A scoring system is in place for this measure - 0-9 indicates a minor colostomy impact, 10-38 indicates a major colostomy impact. | Week 52 | 
| Rate of parastomal hernia | Quantitative frequency of hernia formation | Week 6 | 
| Rate of parastomal hernia | Quantitative frequency of hernia formation. | Week 26 | 
| Rate of parastomal hernia | Quantitative frequency of hernia formation | Week 52 | 
| Rate of AE/SAE related to intervention procedure | Safety data | 30 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, colostomy, colon cancer, feasibility study, cancer