Multi-interventional Program to Reduce Chronic Ileoanal Pouch Leaks in UC

NCT04939025 | Unknown

• 1 other identifier: 271078
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this quality improvement project is to increase the one year anastomotic integrity rate in patients having had completion proctectomy and pouch reconstruction for Ulcerative Colitis by the routine and quality controlled implementation of a multi-interventional program thereby improving long-term pouch function and survival.

Conditions

Ulcerative Colitis

Keywords

ileoanal pouch, IPAA, pouch, ulcerative colitis, leak

Outcome Measures

Primary Outcomes (1)

• Leak rate

  Anastomotic integrity at one year postoperatively defined as the absence of presacral collections, anastomotic fistula and severe anastomotic stricture (not amenable for digital dilatation by rectal exam).

  1 year

Secondary Outcomes (14)

• Cumulative anastomotic dehiscence rate

  18 month

• QOL

  3,6,12 and 18 months

• Protocol compliance

  18 month

• ICG

  Operative

• CRP

  30 days

Study Arms (2)

Historic cohort

NO INTERVENTION

Multi-interventional program cohort

OTHER

Procedure: Multi-interventional program

Interventions

Multi-interventional program PROCEDURE

1. Preoperative oral antibiotics and antibiotic enema of the rectal stump prior to the surgery 2. Routine and tailored lengthening measures of the mesentery 3. Intraoperative control of pouch vascularization using ICG 4. Early diagnosis and active assessment of the integrity of the anastomosis. 1. Routine CRP-measurements at day 4 and 6 (after removal pouch catheter) in the non-diverted pouches with CT-scan with rectal contrast if any suspicion on a leak (elevated or rise in CRP. symptoms). 2. Routine CRP-measurements at day 4 in the diverted pouches with endoscopy 10-14 days after pouch creation. 5. Endosponge vacuum assisted closure (EVAC) of the anastomotic defect aiming to close the defect within 10-14 days after diagnosis. 6. MRI assessment of the pouch after stoma closure preferably at one year to rule out chronic sepsis mimicking pouchitis or Crohn's disease.

Multi-interventional program cohort

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Ulcerative Colitis
• Diagnosis of Crohn's disease limited to the colon without any history of perianal disease
• Modified two or three stage restorative proctocolectomy
• Age above 18
• Able to fill in questionnaires in local language and to come to out-patient-clinic visits;

You may not qualify if:

• Known allergy to ICG, or iodide allergy.
• Pregnancy
• Redo pouch operation
• Age under 18

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Mohammed Deputy

CONTACT

+447958395012; m.deputy@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The MIRACLE study is an international multicenter clinical effectiveness study, whereby the current local practice (control cohort) will be evaluated, and subsequently compared to the results after implementation of the multi-interventional program (intervention cohort).

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2025
• Last Updated: June 25, 2021

Record last verified: 2021-06