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

Not Applicable

Completed

• Conditions: Sigmoid Cancer; Rectal Cancer
• Interventions: Device: Fluorescence angiography with indocianyne green

• Registration Number: NCT03390517
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2017-11-09
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-04
• Primary Completion: 2019-08-22
• Status Verified: 2019-09
• Study Completion: 2019-09-22
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG group	Fluorescence angiography with indocianyne green	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.

Primary Outcome Measures

Name	Time	Method
Anastomotic Leak Rate	0 to 30 days

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation