Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Completed · Not applicable

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT06146335

Run by

Weill Medical College of Cornell University

People needed

11

Starts

2024-01-03

Expected to finish

2025-05-31

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.
• Patients age 18 years and older.
• All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
• Patients will be included regardless of preoperative medications (untreated, steroids, biologics)

You may not qualify if…

• Patients under 18 years of age.
• Pregnant patients.
• Patient does not speak English
• Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation

Where it is running

• Weill Cornell Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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