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

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.

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Key information

Conditions

Rectal Cancer Anastomotic Leak Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Sigmoid Cancer Sigmoid Diseases Sigmoid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluorescence angiography with indocianyne green

Device

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.

Primary outcomes

Anastomotic Leak Rate

Time frame: 0 to 30 days

Sponsors and collaborators

Lead sponsor

State Scientific Centre of Coloproctology, Russian Federation

Other Gov

Registry information

Acronym: FLAG

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jan 4, 2018
Registry last updated: Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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