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Clinical Trial Summary

RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction. DESIGN Randomised superiority study POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum INTERVENTION Kono S and end to end hand sewn anastomosis USUAL CARE Side to side stapled anastomosis OUTCOME Endoscopic recurrence (local and central reading) at 6 months SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients KEYWORDS Crohn, ileocolic resection, recurrence


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05246917
Study type Interventional
Source IRCCS San Raffaele
Contact vittoria bellato, MD
Phone +447827422840
Email vittoria.bellato@gmail.com
Status Recruiting
Phase N/A
Start date May 25, 2022
Completion date December 31, 2024

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