Ulcerative ColitisNCT04719169
MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses
A study testing Dynamic MRI enema and Fluoroscopic enema in people with Ulcerative Colitis and Ileal Pouch, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process, participant experience and study management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Ileal Pouch, Anastomotic Leak
- What is being tested?
- Dynamic MRI enema and Fluoroscopic enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2017to 24 Feb 2020
- 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
- History of colonic / anterior resection with low pelvic anastomosis including: ileorectal anastomosis, ileal pouch-anal anastomosis, colorectal anastomosis.
- Clinical requirement for assessment of anastomotic integrity (e.g. prior to reversal of defunctioning stoma)
- Ambulatory Patient
- Over 18 years of age
Who cannot join
- History of gadolinium allergy
- Contraindication to MRI
- Known inability to tolerate MRI (e.g. claustrophobia)
- Known inability to maintain anal continence
- Unable or unwilling to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study of MRI-Enema and Water Soluble Contrast Enema in the Assessment of Colorectal Anastomotic Integrity Prior to Stoma Reversal
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process, participant experience and study management.
Read the detailed description
Both examinations will be performed ideally on the same day or a maximum of 7 days apart. The order of the two tests will be directed according to scan appointment availability. The WSCE will take place at St Marks Hospital London. Due to the MRI capacity at LNWH trust the MRI-Enema will take place at Number 9 Harley Street, London. A service level agreement will be in place for the scans to occur, and St Marks Seedcorn funding has already been awarded to fund the MRI scans. The patients will be asked to fill in a survey to assess their experience immediately after each test in each location.
MRI-Enema:
A 16Fr Foley catheter is introduced per-anus with the patient in a left lateral decubitus position on the MRI scanner table. If the anastomosis was low (within 5 cm of anorectal junction) the catheter will be taped to the skin to maintain its position. In the event of a mid-rectal or upper rectal anastomosis (>5 cm from anorectal junction), the catheter balloon may be filled with 2-5mls of water and withdrawn to a location at the top of the anal sphincter complex. In both instances, after catheter insertion the patient is then re-positioned to a supine body position.
The MRI protocol used is detailed below. In summary, T2 and T1 (with fat suppression) sequences are obtained prior to filling the lumen with contrast to assess the presence of any pre-sacral and peri-anastomotic fluid, to identify the presence of haematoma and to ensure the catheter is appropriately sited with the catheter tip above the anal canal and close to the anastomosis, ideally within 3cm.
The enema comprises a mixture of normal saline (400mls) and contrast agent (Gadovist, 4mls) to produce a 1% contrast solution which part fills a standard contrast enema bag and delivery system. The bag is attached to a fixed hook located 100cm above the scanner table height, such that fluid will deliver from the bag via the catheter according to gravity.
Dynamic MRI sequences are then performed with the delivery tube open to maximise flow of contrast into the residual rectum/neo-rectum or ileo-anal pouch.
Following the dynamic sequences, further axial and coronal images are acquired in order to identify the presence of leaked fluid within the pelvis.
After all images have been acquired, the enema bag is then placed on the floor to allow drainage of enema solution back into bag prior to removal of catheter.
MRI Protocol:
Pre Enema T2 sagittal Pre Enema T2 sagittal Fat-sat Pre Enema T2 axial SFOV Pre Enema T1 axial Filling Phase Dynamic sagittal Post Enema 3D volumetric T1 sagittal SFOV Post Enema T2 axial fat sat Post Enema T2 coronal fat sat
WSCE:
The WSCE is undertaken according to standard practice. As with the MRI, a 16Fr Foley catheter is introduced per anus with the patient in the left lateral decubitus position. Having affixed the catheter in place according to the height of the anastomosis above the anorectal junction as described above, water-soluble contrast (Gastrografin) is introduced via an enema delivery bag system as described above.
Radiographic images are then acquired with the patient in the supine and lateral decubitus positions as required in order to delineate the anastomosis and any related leak of contrast. The bag is then placed on the floor to allow drainage of fluid and the catheter removed.
Patients will be asked to complete a questionnaire immediately following both examinations. Questions will be targeted to evaluate anxiety, comfort, embarrassment and confidence in the test's outcome.
Reference standard = Consensus of both tests (WSCE and MRI-Enema) with agreement between two radiologists and in agreement with referring consultant /clinical assessment including findings at clinical examination where applicable.
- Conditions
- Ulcerative Colitis, Ileal Pouch, Anastomotic Leak
- Being tested
- Dynamic MRI enema, Fluoroscopic enema
- Medical subject headings
- Colitis, Ulcerative, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic MRI enemaDiagnostic test
Dynamic MRI enema
Fluoroscopic enemaDiagnostic test
Fluoroscopic enema
| Study group | Role | What they receive |
|---|---|---|
| Post-low pelvic colorectal anastomosis | Experimental | Single armed study Receives: Diagnostic Test: Dynamic MRI enema; Diagnostic Test: Fluoroscopic enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
The test accuracy of (1) water-soluble contrast enema (WCSE) for the detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
As above
Measured: Up to 36 months
The test accuracy of (2) MRI-Enema for detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
As above
Measured: Up to 36 months
Secondary outcomes (2)
(1) The comparative sensitivity for reported outcome variables relevant to investigation of pelvic intestinal anastomotic integrity. Including but not limited to: collection, fistula, fibrosis, lymphadenopathy, stenosis.
As above
Measured: Up to 36 months
(2) Patient experience of WSCE vs MRI-Enema particularly relating to anxiety, comfort and embarrassment assessed on a non-validated five point questionnaire entitled 'MRI-Enema Study Patient Questionnaire v1.1'.
13 statements are answered in tick boxes on a five-point scale categorised to: 'Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree'. For nearly all statements, agreement is a better outcome.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start13 Jun 2017
- Primary completion1 Apr 2019
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719169
- Sponsor's protocol ID
- mrianastv1.327102016
- Other IDs
- 191029
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be available to members of the research team included in the study delegation log and members of the patient's normal clinical care team.
Publications
Worley G, Burling D, Corr A, Clark S, Baldwin-Cleland R, Faiz O, Jenkins J. MRI-enema for the assessment of pelvic intestinal anastomotic integrity. Colorectal Dis. 2021 Jul;23(7):1890-1899. doi: 10.1111/codi.15688. Epub 2021 May 16.
PubMed 33900000
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of MRI-Enema and Water Soluble Contrast Enema in the Assessment of Colorectal Anastomotic Integrity Prior to Stoma Reversal
- ClinicalTrials.gov ID
- NCT04719169
- Acronym / sponsor ID
- mrianastv1.327102016
- Conditions
- Ulcerative Colitis, Ileal Pouch, Anastomotic Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 22 Jan 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 protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process, participant experience and study management.
Detailed description
Both examinations will be performed ideally on the same day or a maximum of 7 days apart. The order of the two tests will be directed according to scan appointment availability. The WSCE will take place at St Marks Hospital London. Due to the MRI capacity at LNWH trust the MRI-Enema will take place at Number 9 Harley Street, London. A service level agreement will be in place for the scans to occur, and St Marks Seedcorn funding has already been awarded to fund the MRI scans. The patients will be asked to fill in a survey to assess their experience immediately after each test in each location.
MRI-Enema:
A 16Fr Foley catheter is introduced per-anus with the patient in a left lateral decubitus position on the MRI scanner table. If the anastomosis was low (within 5 cm of anorectal junction) the catheter will be taped to the skin to maintain its position. In the event of a mid-rectal or upper rectal anastomosis (>5 cm from anorectal junction), the catheter balloon may be filled with 2-5mls of water and withdrawn to a location at the top of the anal sphincter complex. In both instances, after catheter insertion the patient is then re-positioned to a supine body position.
The MRI protocol used is detailed below. In summary, T2 and T1 (with fat suppression) sequences are obtained prior to filling the lumen with contrast to assess the presence of any pre-sacral and peri-anastomotic fluid, to identify the presence of haematoma and to ensure the catheter is appropriately sited with the catheter tip above the anal canal and close to the anastomosis, ideally within 3cm.
The enema comprises a mixture of normal saline (400mls) and contrast agent (Gadovist, 4mls) to produce a 1% contrast solution which part fills a standard contrast enema bag and delivery system. The bag is attached to a fixed hook located 100cm above the scanner table height, such that fluid will deliver from the bag via the catheter according to gravity.
Dynamic MRI sequences are then performed with the delivery tube open to maximise flow of contrast into the residual rectum/neo-rectum or ileo-anal pouch.
Following the dynamic sequences, further axial and coronal images are acquired in order to identify the presence of leaked fluid within the pelvis.
After all images have been acquired, the enema bag is then placed on the floor to allow drainage of enema solution back into bag prior to removal of catheter.
MRI Protocol:
Pre Enema T2 sagittal Pre Enema T2 sagittal Fat-sat Pre Enema T2 axial SFOV Pre Enema T1 axial Filling Phase Dynamic sagittal Post Enema 3D volumetric T1 sagittal SFOV Post Enema T2 axial fat sat Post Enema T2 coronal fat sat
WSCE:
The WSCE is undertaken according to standard practice. As with the MRI, a 16Fr Foley catheter is introduced per anus with the patient in the left lateral decubitus position. Having affixed the catheter in place according to the height of the anastomosis above the anorectal junction as described above, water-soluble contrast (Gastrografin) is introduced via an enema delivery bag system as described above.
Radiographic images are then acquired with the patient in the supine and lateral decubitus positions as required in order to delineate the anastomosis and any related leak of contrast. The bag is then placed on the floor to allow drainage of fluid and the catheter removed.
Patients will be asked to complete a questionnaire immediately following both examinations. Questions will be targeted to evaluate anxiety, comfort, embarrassment and confidence in the test's outcome.
Reference standard = Consensus of both tests (WSCE and MRI-Enema) with agreement between two radiologists and in agreement with referring consultant /clinical assessment including findings at clinical examination where applicable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-low pelvic colorectal anastomosis | Experimental | Diagnostic Test: Dynamic MRI enema, Diagnostic Test: Fluoroscopic enemaSingle armed study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of colonic / anterior resection with low pelvic anastomosis including: ileorectal anastomosis, ileal pouch-anal anastomosis, colorectal anastomosis.
- Clinical requirement for assessment of anastomotic integrity (e.g. prior to reversal of defunctioning stoma)
- Ambulatory Patient
- Over 18 years of age
Key exclusion criteria (5 listed)
- History of gadolinium allergy
- Contraindication to MRI
- Known inability to tolerate MRI (e.g. claustrophobia)
- Known inability to maintain anal continence
- Unable or unwilling to consent
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 |
|---|---|---|
| Dynamic MRI enemaDynamic MRI enema | Diagnostic test | Post-low pelvic colorectal anastomosis |
| Fluoroscopic enemaFluoroscopic enema | Diagnostic test | Post-low pelvic colorectal anastomosis |
Primary outcome
The test accuracy of (1) water-soluble contrast enema (WCSE) for the detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
Time frame: Up to 36 months
As above
The test accuracy of (2) MRI-Enema for detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment.
Time frame: Up to 36 months
As above
2 secondary outcomes
(1) The comparative sensitivity for reported outcome variables relevant to investigation of pelvic intestinal anastomotic integrity. Including but not limited to: collection, fistula, fibrosis, lymphadenopathy, stenosis.
Time frame: Up to 36 months
(2) Patient experience of WSCE vs MRI-Enema particularly relating to anxiety, comfort and embarrassment assessed on a non-validated five point questionnaire entitled 'MRI-Enema Study Patient Questionnaire v1.1'.
Time frame: Up to 36 months
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 22 Jan 2021.
- Derived from this study: PubMed 33900000Worley G, Burling D, Corr A, Clark S, Baldwin-Cleland R, Faiz O, Jenkins J. MRI-enema for the assessment of pelvic intestinal anastomotic integrity. Colorectal Dis. 2021 Jul;23(7):1890-1899. doi: 10.1111/codi.15688. Epub 2021 May 16.
- Individual participant dataSharing planned: No. Individual participant data will be available to members of the research team included in the study delegation log and members of the patient's normal clinical care team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic MRI enema and Fluoroscopic enema in people with Ulcerative Colitis and Ileal Pouch, run by London North West Healthcare NHS Trust 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 4 inclusion and 5 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 22 Jan 2021. 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?
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?
The test accuracy of (1) water-soluble contrast enema (WCSE) for the detection of colorectal anastomotic leaks. The reference standard will be consensus of Radiologist interpretation and surgical clinical assessment. (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719169, which also lists 1 linked publication.
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 22 Jan 2021.