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Crohn's surgery showdown: which technique wins?

NCT ID NCT04578392

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 compared two surgical methods for removing diseased intestine in people with Crohn's disease: one that cuts the main artery high up, and one that spares the mesentery (the tissue holding the intestine). The goal was to see which technique better prevents the disease from coming back within 6 months. Only 13 adults with limited Crohn's disease took part before the study was stopped early.

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 (high ligation vs. mesenteric sparing ileocolic resection)
What this could lead to
If successful, this could help identify a better surgical approach to reduce the chance of Crohn's disease returning after surgery.
What could go wrong
The trial was terminated early with very few participants (13), so results are limited and may not be reliable. It is unclear if either technique is truly better.

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

13 people

The number who actually took part.

Started

Jul 2020

Finished

Dec 2023

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 65 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: * Males and females 18-65 years of age. * Isolated ileocolic Crohn's disease of \<30 cm in length * Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted. * Ability to comply with protocol * Competent and able to provide written informed consent * Medically refractory disease or inability to tolerate ongoing medical therapy Exclusion Criteria:Inability to give informed consent. * Patients less than 18 years of age * Patients undergoing repeat ileocolic resection * Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection. * Patients with \>30 cm of terminal ileal disease * Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve * Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy * Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. * Specific exclusions; Evidence of hepatitis B, C, or HIV * History of cancer including melanoma (with the exception of localized skin cancers) * Emergent indication for an operation * Pregnant or breast feeding. * History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity * Inability to follow up at respective sites for the primary endpoint

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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 disease

Contacts and locations

Locations

  • Cedars-Sinai Hospital System

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Humanitas

    Rozzano, Milano, 20089, Italy

  • Mt. Sinai

    Toronto, Ontario, M5G 1X5, Canada

  • St Mark's Hospital and Academic Institution

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Stanford University School of Medicine

    Stanford, California, 94305, United States

More trials for these conditions

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