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

Recruiting

Prospective Randomized Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis in the Prevention of Post-operative Recurrence of Crohn's Disease

Who can join

Ages 18 to 90 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Weill Medical College of Cornell University · Participants: 600 · Started: Mar 12, 2014

Contact the study team

Official record on ClinicalTrials.gov — NCT03256240

Locations in the U.S.

New YorkWeill Cornell Medical College, New York

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.