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NCT Number: NCT05163873

ExPECT: Extraperitoneal End Colostomy Trial

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.

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Key information

Conditions

Colostomy Stoma Cancer of Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and Vale University Health Board, Cardiff, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Extra-peritoneal

Procedure

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

Primary outcomes

  1. Assessing the feasibility of the trial based on recruitment rate

    Time frame: Consent

    number of eligible patients who consent

  2. Assessing the feasibility of the trial based on data completeness

    Time frame: Week 6

    % follow up data collected for 80% of participants

  3. Assessing the feasibility of the trial based on surgeon involvement

    Time frame: set up

    number of surgeons at sites willing to be involved in the trial

  4. Assessing the feasibility of the trial based on recruitment within sites

    Time frame: consent

    number of patients recruited at each site to be at least 10

  5. Assessing the feasibility of the trial based on surgeon training

    Time frame: set up

    ability to successfully train surgeons taking part

  6. Assessing the feasibility of the trial based on surgeon compliance with the intervention

    Time frame: month 12

    80% compliance with the correct technique required

  7. Assessing the feasibility of the trial based on collection of key outcomes

    Time frame: week 6, month 6 and month 12

    collection of colostomy impact score, EQ-5D and rate of parastomal hernia

  8. Assessing the feasibility of the trial based on overall QoL reported in intervention group compared with standard care group

    Time frame: week 6, month 6 and month 12

    QoL data to be 80% or more of that in the standard care group

Sponsors and collaborators

Lead sponsor

Swansea Bay University Health Board

Other

Collaborators

  • Swansea University

Registry information

Official study title

ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase

Acronym: ExPECT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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