Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Crohn Disease

Treatments: Procedure: Side-to-side anastomosis (SSa); Procedure: Kono-S anastomosis (KSa)

Study type: Interventional

Funder types: Other

Identifiers

NCT06146335

23-07026235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

11 participants in 2 patient groups

Kono-S anastomosis (KSa)

Experimental group

Description:

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

Treatment:

Procedure: Kono-S anastomosis (KSa)

side-to-side anastomosis (SSa)

Active Comparator group

Description:

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

Treatment:

Procedure: Side-to-side anastomosis (SSa)