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OpenTrials
Completed

NCT Number: NCT06146335

Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Kono-S anastomosis (KSa)

Procedure

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

Side-to-side anastomosis (SSa)

Procedure

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

Primary outcomes

  1. Changes in composition of the microbiome between treatment groups

    Time frame: At the time of the surgery

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

  2. Changes in the immune cell environment between treatment groups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Crohn's & Colitis Foundation of America, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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