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Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

NCT06146335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Fabrizio Michelassi, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146335 on ClinicalTrials.gov