Status:
COMPLETED
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Crohn's & Colitis Foundation of America, Inc.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 gu...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06146335
Start Date
January 3 2024
End Date
May 31 2025
Last Update
November 18 2025
Active Locations (1)
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1
Weill Cornell Medical Center
New York, New York, United States, 10065