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

Recruiting now · Not applicable

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT03256240

Run by

Weill Medical College of Cornell University

People needed

600

Starts

2014-03-12

Expected to finish

2036-12-31

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Universitätsklinik Würzburg — Würzburg, Wurzburg, Germany (enrolling)
• Charité Campus Benjamin Franklin — Berlin, Germany (enrolling)
• Theresien Hospital and St. Hedwigs Clinic gGmbH — Mannheim, Germany (enrolling)
• Azienda Ospedaliero-Universitaria Careggi — Florence, Florence, Italy (enrolling)
• Humanitas University Hospital — Rozzano, Milan, Italy (enrolling)
• Policlinico University Hospital — Naples, Italy (enrolling)
• University Clinics Gasthuisberg Herestraat — Leuven, Belgium (enrolling)
• Weill Cornell Medical College — New York, New York, United States (enrolling)
• Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Helsinki University Hospital — Helsinki, Helsinki, Finland
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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