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

NCT03390517 | Completed

• 1 other identifier: 80
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Sigmoid Cancer

Keywords

fluorescence angiography; indocyanine green; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• Anastomotic Leak Rate

  0 to 30 days

Study Arms (2)

ICG group

EXPERIMENTAL

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.

Device: Fluorescence angiography with indocianyne green

Standard

NO INTERVENTION

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

Interventions

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.

ICG group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years and older
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a planned circular stapled colorectal anastomosis
• Have signed an approved informed consent form for the study

You may not qualify if:

• Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

Location

MeSH Terms

Conditions

Rectal Neoplasms; Sigmoid Neoplasms; Anastomotic Leak

Interventions

Fluorescein Angiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Med.Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 4, 2018
• Study Start: November 9, 2017
• Primary Completion: August 22, 2019
• Study Completion: September 22, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)