Laparoscopic right colectomy with extended mesenteric excision and Kono-S anastomosis for Crohn's of the terminal ileum
Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study.
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Tzaneio General Hospital Academic / other |
| Locations | 1 site (Piraeus, Attica) |
| Trial ID | NCT07231601 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Piraeus, Attica
- General Hospital Of Piraeus "Tzaneio" — Piraeus, Attica, Greece (Recruiting)
Study contacts
- Study coordinator: Panagiotis Dikeakos, Consultant
- Email: dikeakosp@hotmail.com
- Phone: Greece
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.