Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2025-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Kono-S anastomosis (KSa)

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

Group Type EXPERIMENTAL

Kono-S anastomosis (KSa)

Intervention Type PROCEDURE

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

side-to-side anastomosis (SSa)

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

Group Type ACTIVE_COMPARATOR

Side-to-side anastomosis (SSa)

Intervention Type PROCEDURE

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

Interventions

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Kono-S anastomosis (KSa)

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

Intervention Type PROCEDURE

Side-to-side anastomosis (SSa)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No