NCT06146335

Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.

Detailed description

These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
PROCEDURE	Kono-S anastomosis (KSa)	antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery
PROCEDURE	Side-to-side anastomosis (SSa)	side-to-side anastomosis connecting small intestine and colon after surgery

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-11-24
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States