Colostomy StomaExPECTNCT05163873
ExPECT: Extraperitoneal End Colostomy Trial
A study testing Extra-peritoneal in people with Colostomy Stoma and Cancer of Colon, run by Swansea Bay University Health Board at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy Stoma, Cancer of Colon, Surgery
- What is being tested?
- Extra-peritoneal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Dec 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Cardiff and Vale University Health Board
Cardiff
Aneurin Bevan University Health Board
Newport
Swansea Bay University Health Board
Swansea
About this study
Official title: 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.
Read the 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.
- Conditions
- Colostomy Stoma, Cancer of Colon, Surgery, Quality of Life
- Being tested
- Extra-peritoneal
- Keywords
- colostomy, surgery, colon cancer, feasibility study, cancer
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-peritonealProcedure or surgery
Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Extra-peritoneal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the feasibility of the trial based on recruitment rate
number of eligible patients who consent
Measured: Consent
Assessing the feasibility of the trial based on data completeness
% follow up data collected for 80% of participants
Measured: Week 6
Assessing the feasibility of the trial based on surgeon involvement
number of surgeons at sites willing to be involved in the trial
Measured: 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
Measured: consent
Assessing the feasibility of the trial based on surgeon training
ability to successfully train surgeons taking part
Measured: set up
Assessing the feasibility of the trial based on surgeon compliance with the intervention
80% compliance with the correct technique required
Measured: 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
Measured: 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
Measured: week 6, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start9 Dec 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea Bay University Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Sponsor
- Investigators
- Gregory Taylor, Study director, Swansea Bay University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163873
- Sponsor's protocol ID
- 291897
- Acronym
- ExPECT
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share IPD but will discuss with study team if and/or when the request arises.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase
- ClinicalTrials.gov ID
- NCT05163873
- Acronym / sponsor ID
- ExPECT / 291897
- Conditions
- Colostomy Stoma, Cancer of Colon, Surgery, Quality of Life
- Keywords
- colostomy, surgery, colon cancer, feasibility study, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Swansea Bay University Health BoardUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-peritoneal | No intervention | –Surgery technique in the formation of permanent end colostomy |
| Extra-peritoneal | Experimental | Procedure: Extra-peritonealSurgery technique in the formation of permanent end colostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-peritonealSurgery procedure: a non-mesh prophylactic surgical technique to prevent PH | Procedure or surgery | Extra-peritoneal |
Primary outcome
Assessing the feasibility of the trial based on recruitment rate
Time frame: Consent
number of eligible patients who consent
Assessing the feasibility of the trial based on data completeness
Time frame: Week 6
% follow up data collected for 80% of participants
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
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
Assessing the feasibility of the trial based on surgeon training
Time frame: set up
ability to successfully train surgeons taking part
Assessing the feasibility of the trial based on surgeon compliance with the intervention
Time frame: month 12
80% compliance with the correct technique required
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No. No current plan to share IPD but will discuss with study team if and/or when the request arises.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Taylor study director
Swansea Bay University Health Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-peritoneal in people with Colostomy Stoma and Cancer of Colon, run by Swansea Bay University Health Board at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the feasibility of the trial based on recruitment rate (time frame: Consent). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.