Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Study Overview
=================
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.

Official Title
-----------------
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Procedure: Kono-S anastomosis (KSa)
* Procedure: Side-to-side anastomosis (SSa)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kono-S anastomosis (KSa)<br>Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis | Procedure: Kono-S anastomosis (KSa)<br>* antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery<br>|
| Active Comparator: side-to-side anastomosis (SSa)<br>Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis | Procedure: Side-to-side anastomosis (SSa)<br>* side-to-side anastomosis connecting small intestine and colon after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |