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New surgery may keep Crohn's disease at bay after bowel resection

NCT ID NCT03256240

Disease control Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer surgical method called Kono-S anastomosis can better prevent Crohn's disease from returning after bowel surgery compared to the standard side-to-side technique. About 600 adults with Crohn's disease needing bowel resection will be randomly assigned to one of the two procedures. The main goal is to see if the Kono-S method leads to fewer signs of disease recurrence within 6 months and over the long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical procedure (Kono-S anastomosis)
What this could lead to
If successful, this could offer a better surgical option to reduce the chance of Crohn's disease coming back after surgery.
What could go wrong
This is a surgical technique comparison, not a new drug. Results may vary, and long-term benefits are still uncertain until the trial completes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2014

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, Florence, 50134, Italy

  • Baylor College of Medicine

    TERMINATED

    Houston, Texas, 77030, United States

  • Baylor Scott & White Research Institute

    TERMINATED

    Dallas, Texas, 75204, United States

  • Charité Campus Benjamin Franklin

    RECRUITING

    Berlin, 12203, Germany

  • Helsinki University Hospital

    TERMINATED

    Helsinki, Helsinki, 00029, Finland

  • Hospital Universitario Vall d'Hebron

    TERMINATED

    Barcelona, Barcelona, 08035, Spain

  • Humanitas University Hospital

    RECRUITING

    Rozzano, Milan, 20089, Italy

  • Massachusetts General Hospital

    TERMINATED

    Boston, Massachusetts, 02114, United States

  • Policlinico University Hospital

    RECRUITING

    Naples, Italy

  • Theresien Hospital and St. Hedwigs Clinic gGmbH

    RECRUITING

    Mannheim, 68165, Germany

  • University Clinics Gasthuisberg Herestraat

    RECRUITING

    Leuven, 3000, Belgium

  • University of Oklahoma

    TERMINATED

    Oklahoma City, Oklahoma, 73112, United States

  • University of Washington Medical Center

    TERMINATED

    Seattle, Washington, 98195, United States

  • Universitätsklinik Würzburg

    RECRUITING

    Würzburg, Wurzburg, D-97080, Germany

  • Weill Cornell Medical College

    RECRUITING

    New York, New York, 10065, United States

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