Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

NCT06146335 | Completed

• 1 other identifier: 23-07026235
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Changes in composition of the microbiome between treatment groups

  Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.

  At the time of the surgery

• Changes in the immune cell environment between treatment groups

  Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.

  3-6 month, 12-18 month and 60 month post-surgery endoscopy.

Study Arms (2)

Kono-S anastomosis (KSa)

EXPERIMENTAL

Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis

Procedure: Kono-S anastomosis (KSa)

side-to-side anastomosis (SSa)

ACTIVE COMPARATOR

Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis

Procedure: Side-to-side anastomosis (SSa)

Interventions

Kono-S anastomosis (KSa) PROCEDURE

antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery

Kono-S anastomosis (KSa)

Side-to-side anastomosis (SSa) PROCEDURE

side-to-side anastomosis connecting small intestine and colon after surgery

side-to-side anastomosis (SSa)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Crohn's & Colitis Foundation of America, Inc.: collaborator

Study Sites (1)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fabrizio Michelassi, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: January 3, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)