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

Rectal Cancer Clinical Trial

— FLAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390517
• Other study ID #: 80
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: September 22, 2019

Study information

• Verified date: September 2019
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: September 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a planned circular stapled colorectal anastomosis

• Have signed an approved informed consent form for the study

Exclusion Criteria:

• Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.

Related Conditions & MeSH terms

• Rectal Cancer
• Sigmoid Cancer
• Sigmoid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic Leak Rate		0 to 30 days