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ExPECT: Extraperitoneal End Colostomy Trial

NCT05163873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

PROCEDURE

Extra-peritoneal

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

Sponsors & Collaborators

  • Swansea University

    collaborator OTHER

  • Swansea Bay University Health Board

    lead OTHER

Principal Investigators

  • Gregory Taylor · Swansea Bay University Health Board

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163873 on ClinicalTrials.gov