Laparoscopic Right Hemicolectomy for Crohn's Disease of the Terminal Ileum Utilizing the Mesenteric Excision and Exclusion
Recruiting · NCT07231601 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tzaneio General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Mesenteric excision and exclusion
What this trial is about
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. Since this is a fairly new technique, the intra and post operative complications will be reviewed. Also endoscopic, clinical and surgical reoccurrence will be reviewed at certain predefined time points post operatively.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- General Hospital Of Piraeus "Tzaneio" - Piraeus, Attica, Greece