NCT03390517

A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 377 (actual)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 using fluorescence angiography with indocyanine green and without this method.

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 surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.

Conditions

• Rectal Cancer
• Sigmoid Cancer

Interventions

Type	Name	Description
DEVICE	Fluorescence angiography with indocianyne green	The fluorescence angiography was performed after mobilization of the bowel, transection of the rectum, division of the rectal and colon mesentery and central vessels, before specimen extraction or resection and creation of the anastomosis. This site was selected by the surgeon using his or her best judgment and typical standard of care assessment. After this selection, the anesthesiologist administered a bolus of 1 to 2 ml indocianyne green intravenously. Perfusion of the colon was visualized and assessed via fluorescence angiography and the line of demarcation between perfused and nonperfused tissue was noted and compared with the initial planned transection point.

Timeline

• Start date: 2017-11-09
• Primary completion: 2019-08-22
• Completion: 2019-09-22
• First posted: 2018-01-04
• Last updated: 2019-09-25

Locations

1 site across 1 country: Russia