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Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)
The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
Start Date
July 13, 2023
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2027
Last Updated
December 18, 2023
165
ESTIMATED participants
stapled side-to-side anastomosis
PROCEDURE
Handsewn anastomosis
PROCEDURE
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
NCT07245394
NCT07089420
Data Source & Attribution
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