Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis
Not applicable · Testing side-to-side functional end anastomosis and Kono-S analstomosis · 15 sites · Weill Medical College of Cornell University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing side-to-side functional end anastomosis and Kono-S analstomosis to see if it can prevent disease or complications. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 90
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 600 participants are expected to take part.
- Start date: 2014-03-12.
- Main results expected around 2030-07-31 (estimate from the record).
- 15 study sites listed (8 marked recruiting) in Belgium, Finland, Germany, Italy and Spain and 1 more countries.
Main thing being measured
- Post-operative endoscopic remission of Crohn's disease between 3 and 6 months after surgery (3-6 months after surgery)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Weill Medical College of Cornell University |
| Collaborators | Crohn's and Colitis Foundation; The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 600 (estimated) |
| Start date | 2014-03-12 |
| Primary completion (est.) | 2030-07-31 |
| First posted | 2017-08-21 |
| Last updated | 2026-05-14 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT03256240 |
Interventions
- side-to-side functional end anastomosis (Other)
type of anastomosis - Kono-S analstomosis (Other)
antimesenteric anastomosis
Full eligibility criteria (from the record)
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.
Locations (15)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
| Charité Campus Benjamin Franklin | Berlin | Germany | Recruiting |
| Theresien Hospital and St. Hedwigs Clinic gGmbH | Mannheim | Germany | Recruiting |
| Universitätsklinik Würzburg | Würzburg, Wurzburg | Germany | Recruiting |
| Policlinico University Hospital | Naples | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi | Florence, Florence | Italy | Recruiting |
| Humanitas University Hospital | Rozzano, Milan | Italy | Recruiting |
| Hospital Universitario Vall d'Hebron | Barcelona, Barcelona | Spain | Terminated |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.