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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

side-to-side functional end anastomosis

type of anastomosis

OTHER

Kono-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