RecruitingNot ApplicableNCT03256240

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

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

Sponsor

Weill Medical College of Cornell University

Enrollment

600 participants

Start Date

Mar 12, 2014

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of bowel-reconnection surgery techniques in Crohn's disease patients to see which one reduces the chances of the disease coming back after surgery. **You may be eligible if...** - You have Crohn's disease affecting your small intestine or the junction of the small and large intestine, and you need surgery for the first time - You are 18 years or older - You have any form of Crohn's disease (blockages, inflammation, or fistulas) **You may NOT be eligible if...** - You are under 18 - Your Crohn's disease has already come back after a previous surgery (recurrent disease) - You are pregnant - You have more than one separate area of active disease requiring multiple surgical procedures - You have disease extending into the colon beyond the first part (cecum/ascending colon) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERside-to-side functional end anastomosis

type of anastomosis

OTHERKono-S analstomosis

antimesenteric anastomosis

Locations(15)

Massachusetts General Hospital

Boston, Massachusetts, United States

Weill Cornell Medical College

New York, New York, United States

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

University Clinics Gasthuisberg Herestraat

Leuven, Belgium

Helsinki University Hospital

Helsinki, Helsinki, Finland

Universitätsklinik Würzburg

Würzburg, Wurzburg, Germany

Charité Campus Benjamin Franklin

Berlin, Germany

Theresien Hospital and St. Hedwigs Clinic gGmbH

Mannheim, Germany

Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, Italy

Humanitas University Hospital

Rozzano, Milan, Italy

Policlinico University Hospital

Naples, Italy

Hospital Universitario Vall d'Hebron

Barcelona, Barcelona, Spain

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NCT03256240

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