search
Back to results

MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses

Primary Purpose

Ulcerative Colitis, Ileal Pouch, Anastomotic Leak

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dynamic MRI enema
Fluoroscopic enema
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of colonic / anterior resection with low pelvic anastomosis including: ileorectal anastomosis, ileal pouch-anal anastomosis, colorectal anastomosis.
  2. Clinical requirement for assessment of anastomotic integrity (e.g. prior to reversal of defunctioning stoma)
  3. Ambulatory Patient
  4. Over 18 years of age

Exclusion Criteria:

  1. History of gadolinium allergy
  2. Contraindication to MRI
  3. Known inability to tolerate MRI (e.g. claustrophobia)
  4. Known inability to maintain anal continence
  5. Unable or unwilling to consent

Sites / Locations

  • St Mark's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-low pelvic colorectal anastomosis

Arm Description

Single armed study

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

(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
(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.

Full Information

First Posted
April 16, 2018
Last Updated
January 18, 2021
Sponsor
London North West Healthcare NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04719169
Brief Title
MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses
Official Title
Comparison Study of MRI-Enema and Water Soluble Contrast Enema in the Assessment of Colorectal Anastomotic Integrity Prior to Stoma Reversal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ileal Pouch, Anastomotic Leak

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-low pelvic colorectal anastomosis
Arm Type
Experimental
Arm Description
Single armed study
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic MRI enema
Intervention Description
Dynamic MRI enema
Intervention Type
Diagnostic Test
Intervention Name(s)
Fluoroscopic enema
Intervention Description
Fluoroscopic enema
Primary Outcome Measure Information:
Title
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.
Description
As above
Time Frame
Up to 36 months
Title
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.
Description
As above
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
(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.
Description
As above
Time Frame
Up to 36 months
Title
(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'.
Description
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.
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
St Mark's Hospital
City
London
ZIP/Postal Code
HA1 3J
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33900000
Citation
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.
Results Reference
derived

Learn more about this trial

MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses

We'll reach out to this number within 24 hrs