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

State Scientific Centre of Coloproctology, Russian Federation

Status: Completed

Conditions: Sigmoid Cancer; Rectal Cancer

Treatments: Device: Fluorescence angiography with indocianyne green

Study type: Interventional

Funder types: Other

Identifiers

NCT03390517

80

Details and patient eligibility

About

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.

Full 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.

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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377 participants in 2 patient groups

ICG group

Experimental group

Description:

A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice with the addition of intraoperative imaging using fluorescence angiography with indocianyne green to assess colon and rectal tissue perfusion.

Treatment:

Device: Fluorescence angiography with indocianyne green

Standard

No Intervention group

Description:

A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice.