Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
Recruiting · NCT03256240 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
Kono-S analstomosisside-to-side functional end anastomosis
What this trial is about
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 can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
15 locations listed across 5 US states.
- 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
- Charité Campus Benjamin Franklin - Berlin, Germany
- University Clinics Gasthuisberg Herestraat - Leuven, Belgium
- Theresien Hospital and St. Hedwigs Clinic gGmbH - Mannheim, Germany
- Policlinico University Hospital - Naples, Italy
- Hospital Universitario Vall d'Hebron - Barcelona, Barcelona, Spain
- Azienda Ospedaliero-Universitaria Careggi - Florence, Florence, Italy
- Helsinki University Hospital - Helsinki, Helsinki, Finland
- Humanitas University Hospital - Rozzano, Milan, Italy
- Universitätsklinik Würzburg - Würzburg, Wurzburg, Germany