Clinical trial Recruiting at 1 site Observational Ages 16 and up

Laparoscopic right colectomy with extended mesenteric excision and Kono-S anastomosis for Crohn's of the terminal ileum

Official title: Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.

Run by Tzaneio General Hospital · NCT07231601 · Data updated 2026-11-12

This will test whether combining laparoscopic right colectomy with extended mesenteric excision and the Kono-S anastomosis helps people with terminal ileum Crohn's by lowering complications and recurrence.

Quick facts

Study typeObservational
Ages16 Years and up
SexAll
Enrollment50 (estimated)
SponsorTzaneio General Hospital
Academic / other
Locations1 site (Piraeus, Attica)
StatusRecruiting
StartedJanuary 1, 2022
Main results expectedDecember 31, 2027
Study endsDecember 31, 2032
Registry record updatedNovember 17, 2025
Trial IDNCT07231601 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 16 with ileocolic or terminal ileal Crohn's disease who have an indication for elective resection, can provide informed consent, and can complete required preoperative imaging and follow-up are eligible.

Probably not a fit

Patients requiring emergency surgery, those who are pregnant or breastfeeding, those with recent major medical events (for example recent myocardial infarction or unstable cardiac disease), or those whose disease is not localized to the terminal ileum are unlikely to benefit from this specific approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study enrolling adults with Crohn's disease of the terminal ileum who require ileocolic resection. Participants will undergo a laparoscopic segmental right colectomy combining extended mesenteric excision and the Kono-S anastomosis, a combined approach termed mesenteric excision and exclusion. Investigators will record intraoperative and postoperative complications and follow patients at predefined time points with endoscopy, clinical assessment, and imaging to document endoscopic, clinical, and surgical recurrence. Because the combination is relatively new, the protocol emphasizes safety monitoring and recurrence outcomes rather than randomized comparison.

Why it matters

Potential benefit: If successful, this combined surgical approach could reduce anastomotic recurrence and decrease the need for repeat intestinal surgeries.

How similar studies have gone: Early series and nonrandomized reports suggest extended mesenteric excision and the Kono-S anastomosis may lower recurrence, but high-quality randomized and long-term comparative data remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Males and females aged \>16 years
* Ileocolic disease or disease of the terminal ileum with an indication for resection
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
* All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))
* Ability to comply with protocol.
* Competent and able to provide written informed consent.

Exclusion Criteria:

* Inability to give informed consent.
* Patients less than 16 years of age.
* Clinically significant medical conditions within the six months before the operation : 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.
* History of cancer \< 5 years which might influence patients prognosis
* Emergent operation.
* Pregnant or breast feeding.
* Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Where it's running

  • General Hospital Of Piraeus "Tzaneio"
    Piraeus, Attica, Greece
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.