MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses

NCT04719169 | Completed DMC

• 2 other identifiers: mrianastv1.327102016191029
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Ileal Pouch; Anastomotic Leak

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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.

  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'.

  Up to 36 months

Study Arms (1)

Post-low pelvic colorectal anastomosis

EXPERIMENTAL

Single armed study

Diagnostic Test: Dynamic MRI enema; Diagnostic Test: Fluoroscopic enema

Interventions

Dynamic MRI enema DIAGNOSTIC_TEST

Dynamic MRI enema

Post-low pelvic colorectal anastomosis

Fluoroscopic enema DIAGNOSTIC_TEST

Fluoroscopic enema

Post-low pelvic colorectal anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

St Mark's Hospital

London, HA1 3J, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33900000 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: January 22, 2021
• Study Start: June 13, 2017
• Primary Completion: April 1, 2019
• Study Completion: February 24, 2020
• Last Updated: January 22, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)