Healing of Colorectal AnastomosesNCT04740957
Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
A study testing Distal limb reintroduction of ileostomy effluent in people with Healing of Colorectal Anastomoses, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healing of Colorectal Anastomoses
- What is being tested?
- Distal limb reintroduction of ileostomy effluent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 1 Jan 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
- Patients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.
Who cannot join
- Inability to communicate in English
- People who lack capacity to consent
- Emergency colorectal resection whilst awaiting elective surgery
- Age <18
- Permanent stoma formation
- People on long term immunosuppressive medication
- People on long term renal replacement therapy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
James Kinross, PhD FRCS, 020 3312 2124, j.kinross@imperial.ac.uk
James Lewis, MBBS, 020 3312 2124, james.lewis1@imperial.ac.uk
About this study
This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.
100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.
Read more
Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.
A subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.
- Conditions
- Healing of Colorectal Anastomoses
- Being tested
- Distal limb reintroduction of ileostomy effluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal limb reintroduction of ileostomy effluentOther
Patients will undergo water soluble contrast enema to confirm anastomotic healing 8 weeks post operatively as per standard practice at Imperial.
Patients will be educated in how to reintroduce ileostomy output to the distal (downstream) loop of their ileostomy. They will be asked to reintroduce 50ml of ileostomy output using a conventional long-tipped bladder syringe daily until surgery to close the stoma.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | No intervention | 100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants. Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected. |
| Distal limb feeding cohort | Experimental | This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.
A subgroup of 20 patients undergoing a resection with a covering ileostomy will be recruited to the intervention arm. Complete healing of the colorectal anastomosis will first be confirmed by water-soluble contrast enema 8 weeks post-operatively (this is standard practice). Patients will be taught how to inject the output from the proximal ileostomy limb into the distal limb (this connects to the colon and thus the colorectal anastomosis) daily until the ileostomy closure date. Receives: Other: Distal limb reintroduction of ileostomy effluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic healing
Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis.
Measured: 1 year
Secondary outcomes (1)
Failure of anastomotic healing
Anastomotic leak detected either by radiological imaging (CT scanning) or a direct return to theatre
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 May 2019
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing of Colorectal AnastomosesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740957
- Sponsor's protocol ID
- IRAS 246354
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
- ClinicalTrials.gov ID
- NCT04740957
- Acronym / sponsor ID
- IRAS 246354
- Conditions
- Healing of Colorectal Anastomoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 5 Feb 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.
This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.
100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.
Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.
A subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | No intervention | –100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants. Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected. |
| Distal limb feeding cohort | Experimental | Other: Distal limb reintroduction of ileostomy effluentThis interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies. A subgroup of 20 patients undergoing a resection with a covering ileostomy will be recruited to the intervention arm. Complete healing of the colorectal anastomosis will first be confirmed by water-soluble contrast enema 8 weeks post-operatively (this is standard practice). Patients will be taught how to inject the output from the proximal ileostomy limb into the distal limb (this connects to the colon and thus the colorectal anastomosis) daily until the ileostomy closure date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.
Key exclusion criteria (7 listed)
- Inability to communicate in English
- People who lack capacity to consent
- Emergency colorectal resection whilst awaiting elective surgery
- Age <18
- Permanent stoma formation
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 |
|---|---|---|
| Distal limb reintroduction of ileostomy effluentPatients will undergo water soluble contrast enema to confirm anastomotic healing 8 weeks post operatively as per standard practice at Imperial. Patients will be educated in how to reintroduce ileostomy output to the distal (downstream) loop of their ileostomy. They will be asked to reintroduce 50ml of ileostomy output using a conventional long-tipped bladder syringe daily until surgery to close the stoma. | Other | Distal limb feeding cohort |
Primary outcome
Anastomotic healing
Time frame: 1 year
Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis.
1 secondary outcome
Failure of anastomotic healing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal limb reintroduction of ileostomy effluent in people with Healing of Colorectal Anastomoses, run by Imperial College London at 1 site 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Kinross, PhD FRCS (020 3312 2124, j.kinross@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic healing (time frame: 1 year). 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 Sep 2023.