Status:
COMPLETED
A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
Lead Sponsor:
State Scientific Centre of Coloproctology, Russian Federation
Conditions:
Rectal Cancer
Sigmoid Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated usin...
Detailed Description
The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surger...
Eligibility Criteria
Inclusion
- Have a planned circular stapled colorectal anastomosis
- Have signed an approved informed consent form for the study
Exclusion
- Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2019
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT03390517
Start Date
November 9 2017
End Date
September 22 2019
Last Update
September 25 2019
Active Locations (1)
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1
State Scientific Centre of Coloproctology
Moscow, Russia, 123423