MedTrace Logo

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

NCT03390517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2019-09-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • State Scientific Centre of Coloproctology, Russian Federation

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2019-08-22
Completion
2019-09-22

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390517 on ClinicalTrials.gov