Status:
UNKNOWN
Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Ulcerative Colitis
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points du...
Detailed Description
Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusi...
Eligibility Criteria
Inclusion
- age ≥ 18
- capability of signing the informed consent
- diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis
- restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated
- ASA (American Society of Anesthesiologists) Physical Status Classification System score ≤ 3
Exclusion
- coexistent malignant tumor of a different ethology
- liver disfunction (MELD score \> 10)
- ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly tolerated injection of ICG)
- pregnancy or breastfeeding
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04695964
Start Date
February 1 2019
End Date
January 1 2021
Last Update
January 15 2021
Active Locations (1)
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1
Charité Campus Benjamin Franklin
Berlin, Germany, 12203