Comparing two surgical techniques for Crohn's disease
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
NA · Weill Medical College of Cornell University · NCT03256240
This study is testing two different surgical methods for Crohn's disease to see which one helps patients have fewer problems after surgery and improves their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Locations | 15 sites (Boston, Massachusetts and 14 other locations) |
| Trial ID | NCT03256240 on ClinicalTrials.gov |
What this trial studies
This study is a multi-center randomized trial that compares the Kono-S anastomosis with the standard side-to-side functional end anastomosis in patients with Crohn's ileitis or ileocolitis requiring surgical resection. The primary aim is to assess postoperative recurrence of Crohn's disease using the Rutgeerts score at various time points, while secondary aims include evaluating quality of life, disease activity, and patient perspectives on surgical treatment. Participants will be followed for up to 120 months to monitor surgical outcomes and recurrence rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Crohn's ileitis or ileocolitis requiring initial surgical resection.
Not a fit: Patients under 18, those with recurrent Crohn's disease, or those requiring multiple resections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with Crohn's disease.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 14 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (TERMINATED)
- Weill Cornell Medical College — New York, New York, United States (RECRUITING)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (TERMINATED)
- Baylor Scott & White Research Institute — Dallas, Texas, United States (TERMINATED)
- Baylor College of Medicine — Houston, Texas, United States (TERMINATED)
- University of Washington Medical Center — Seattle, Washington, United States (TERMINATED)
- University Clinics Gasthuisberg Herestraat — Leuven, Belgium (RECRUITING)
- Helsinki University Hospital — Helsinki, Helsinki, Finland (TERMINATED)
- Universitätsklinik Würzburg — Würzburg, Wurzburg, Germany (RECRUITING)
- Charité Campus Benjamin Franklin — Berlin, Germany (RECRUITING)
- Theresien Hospital and St. Hedwigs Clinic gGmbH — Mannheim, Germany (RECRUITING)
- Azienda Ospedaliero-Universitaria Careggi — Florence, Florence, Italy (RECRUITING)
- Humanitas University Hospital — Rozzano, Milan, Italy (RECRUITING)
- Policlinico University Hospital — Naples, Italy (RECRUITING)
- Hospital Universitario Vall d'Hebron — Barcelona, Barcelona, Spain (TERMINATED)
Study contacts
- Principal investigator: Fabrizio Michelassi, MD — Weill Medical College of Cornell University
- Study coordinator: Koianka Trencheva, Dr.PH,BSN,MS
- Email: kivanova@med.cornell.edu
- Phone: 646-962-2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn's Disease, Crohn's recurrence