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Recruiting NCT03256240

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

Trial Parameters

Condition Crohn's Disease
Sponsor Weill Medical College of Cornell University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2014-03-12
Completion 2030-07-31
Interventions
side-to-side functional end anastomosisKono-S analstomosis

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 Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

Eligibility Criteria

Inclusion Criteria: 1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection. 2. Age of 18 years and older, male and female 3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification 4. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy. Exclusion Criteria: 1. Patients under 18 years of age 2. Patients with recurrent Crohn's 3. Pregnant patients 4. 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. 5. Patients with Crohn's disease extending to the cecum and ascending colon 6. Patients who will need preventive postoperative medical treatment 7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

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