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

NCT ID: NCT03390517

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2019-09-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICG group

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.

Group Type: EXPERIMENTAL

Fluorescence angiography with indocianyne green

Intervention Type: 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.

Standard

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rybakov Evgeny, MD

Dr.Med.Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

State Scientific Centre of Coloproctology

Moscow, , Russia

Countries

Russia

Other Identifiers

80

Identifier Type: -

Identifier Source: org_study_id