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Status:

RECRUITING

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

Lead Sponsor:

Weill Medical College of Cornell University

Collaborating Sponsors:

Crohn's and Colitis Foundation

Conditions:

Crohn's Disease

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

This study proposes a randomized prospective study comparing the Kono-S anastomosis to the standard side-to-side anastomosis.This will be a multi-center randomized prospective trial. Patients with Cro...

Detailed Description

Study Aim: * The primary aim of this study is to compare the postoperative recurrence of CD using the Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and side-to-side func...

Eligibility Criteria

Inclusion

  • Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
  • Age of 18 years and older, male and female
  • All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
  • The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

Exclusion

  • Patients under 18 years of age
  • Patients with recurrent Crohn's
  • Pregnant patients
  • Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery.
  • Patients with Crohn's disease extending to the cecum and ascending colon
  • Patients who will need preventive postoperative medical treatment
  • Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

Key Trial Info

Start Date :

March 12 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2033

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT03256240

Start Date

March 12 2014

End Date

December 31 2033

Last Update

December 17 2025

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

2

Weill Cornell Medical College

New York, New York, United States, 10065

3

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73112

4

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75204