NCT05246917

Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Crohn Disease
• IBD
• Ileocolitis
• Crohn's Ileocolitis

Interventions

Type	Name	Description
PROCEDURE	Handsewn anastomosis	To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-02-18
• Last updated: 2022-05-31

Locations

1 site across 1 country: Italy