Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Not Applicable

• Conditions: Crohn Disease
• Interventions: Procedure: Kono-S anastomosis (KSa); Procedure: Side-to-side anastomosis (SSa)

• Registration Number: NCT06146335
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Study Start: 2024-01-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2033-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. 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.
2. Patients age 18 years and older.
3. All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
4. Patients will be included regardless of preoperative medications (untreated, steroids, biologics)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kono-S anastomosis (KSa)	Kono-S anastomosis (KSa)	Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis
side-to-side anastomosis (SSa)	Side-to-side anastomosis (SSa)	Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis

Primary Outcome Measures

Name	Time	Method
Changes in composition of the microbiome between treatment groups	At the time of the surgery	Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.
Changes in the immune cell environment between treatment groups	3-6 month, 12-18 month and 60 month post-surgery endoscopy.	Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.

Trial Locations

Locations (1)

Weill Cornell Medical Center; 🇺🇸 New York, New York, United States