ExPECT: Extraperitoneal End Colostomy Trial (ExPECT)

ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Surgery; Cancer of Colon; Colostomy Stoma
• Intervention / Treatment: Procedure: Extra-peritoneal

Detailed Description

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).

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 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 ACCEPT progression criteria.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom
    • Cardiff And Vale University Health Board
  • Newport, United Kingdom
    • Aneurin Bevan University Health Board
  • Swansea, United Kingdom
    • Swansea Bay University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the feasibility of the trial based on recruitment rate	number of eligible patients who consent	Consent
Assessing the feasibility of the trial based on data completeness	% follow up data collected for 80% of participants	Week 6
Assessing the feasibility of the trial based on surgeon involvement	number of surgeons at sites willing to be involved in the trial	set up
Assessing the feasibility of the trial based on recruitment within sites	number of patients recruited at each site to be at least 10	consent
Assessing the feasibility of the trial based on surgeon training	ability to successfully train surgeons taking part	set up
Assessing the feasibility of the trial based on surgeon compliance with the intervention	80% compliance with the correct technique required	month 12
Assessing the feasibility of the trial based on collection of key outcomes	collection of colostomy impact score, EQ-5D and rate of parastomal hernia	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	QoL data to be 80% or more of that in the standard care group	week 6, month 6 and month 12

Collaborators and Investigators

• Sponsor: Swansea Bay University Health Board
• Collaborators: Swansea University
• Investigators: Study Director: Gregory Taylor, Swansea Bay University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cancer; surgery; colon cancer; colostomy; feasibility study
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 291897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share IPD but will discuss with study team if and/or when the request arises.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No