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

NCT04939025 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-06-25

No results posted yet for this study

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

Interventions

PROCEDURE

Multi-interventional program

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.

Sponsors & Collaborators

  • London North West Healthcare NHS Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-07-01
Completion
2025-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939025 on ClinicalTrials.gov