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Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis

NCT04766060 · Odense University Hospital · Updated 23 Feb 2021

What is being tested
Fluorescent Imaging
For
Colorectal Cancer; Anastomotic Leak
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 55 people. The full rules are on the registry page.
Where
Denmark
When
Starts or started 1 April 2017, ends 30 Nov 2018. Registered 23 Feb 2021.
Results
None posted yet.

In the researchers' words

A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is suggested that using this procedure the relative risk of AL is reduced about 54-67%. With this project we wish to evaluate the feasibility of the procedure, and, if proven feasible, to plan further studies evaluating the procedure.
ClinicalTrials.gov, NCT04766060

Sites

  • Odense University HospitalOdense, Fyn, Denmark