ExPECT: Extraperitoneal End Colostomy Trial

NCT05163873 | Completed DMC

• 1 other identifier: 291897
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

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

Colostomy Stoma; Cancer of Colon; Surgery; Quality of Life

Keywords

colostomy; surgery; colon cancer; feasibility study; cancer

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Trans-peritoneal

NO INTERVENTION

Surgery technique in the formation of permanent end colostomy

Extra-peritoneal

EXPERIMENTAL

Surgery technique in the formation of permanent end colostomy

Procedure: Extra-peritoneal

Interventions

Extra-peritoneal PROCEDURE

Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH

Extra-peritoneal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swansea Bay University Health Board: lead
• Swansea University: collaborator

Study Sites (3)

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Location

Aneurin Bevan University Health Board

Newport, United Kingdom

Location

Swansea Bay University Health Board

Swansea, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Gregory Taylor

  Swansea Bay University Health Board

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 20, 2021
• Study Start: December 9, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)