Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion
Observational · No treatment assigned · 1 site · Tzaneio General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD), Crohn Disease of Ileum and Kono S Anastomosis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 3 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 50 participants are expected to take part.
- Start date: 2022-01-01.
- Main results expected around 2027-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Greece.
Main thing being measured
- Safety of the procedure (30 days post intervention)
In the researchers’ words
This study is designed for patients requiring surgery for Crohn's disease of the terminal ileum. A combination of laparoscopic segmental right colectomy with extended mesenteric excision and the Kono-s anastomosis will be utilized.
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 | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD); Crohn Disease of Ileum; Kono S Anastomosis; Extended Mesenteric Excision |
| Lead sponsor | Tzaneio General Hospital |
| Enrollment | 50 (estimated) |
| Start date | 2022-01-01 |
| Primary completion (est.) | 2027-12-31 |
| First posted | 2025-11-17 |
| Last updated | 2025-11-17 |
| Official title | Laparoscopic Mesenteric Excision and Exclusion for Crohn's Disease of the Terminal Ileum. A Greek Single Center Study. |
| ClinicalTrials.gov ID | NCT07231601 |
Interventions
- Mesenteric excision and exclusion (Procedure)
Laparoscopic segmental right colectomy and excision of the affected terminal ileum with extended mesenteric excision and open Kono-s anastomosis
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital Of Piraeus "Tzaneio" | Piraeus, Attica | Greece | Recruiting |
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.