NCT03256240Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 5 Aug 2014
- Start date
- 12 Mar 2014
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Crohn's disease
- NCT number
- NCT03256240
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 12 Mar 2014 to the primary completion date, 31 Jul 2030
- 15 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.
Other illness
- 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
Age
- Patients under 18 years of age
Other
- Patients with recurrent Crohn's
- Pregnant patients
- Patients who will need preventive postoperative medical treatment
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinics Gasthuisberg Herestraat Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Charité Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Theresien Hospital and St. Hedwigs Clinic gGmbH Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Universitätsklinik Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Terminated |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Terminated |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Policlinico University Hospital Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Humanitas University Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Terminated |
| Baylor Scott & White Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Terminated |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Terminated |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Terminated |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Terminated |
This page is information, not medical advice. Discuss any trial with your doctor.