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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390517
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rybakov Evgeny, MD, 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Sigmoid Cancer Device: Fluorescence angiography with indocianyne green Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : September 22, 2019

Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: Standard
A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice.



Primary Outcome Measures :
  1. Anastomotic Leak Rate [ Time Frame: 0 to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years and older
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390517


Locations
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Russian Federation
State Scientific Centre of Coloproctology
Moscow, Russian Federation, 123423
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
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Responsible Party: Rybakov Evgeny, MD, Dr.Med.Sc. State Scientific Centre of Coloproctology, Head of Surgical department of oncoproctology, Moscow, Russian Federation, State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03390517    
Other Study ID Numbers: 80
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation:
fluorescence angiography
indocyanine green
anastomotic leakage
Additional relevant MeSH terms:
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Sigmoid Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Colonic Neoplasms
Colonic Diseases
Sigmoid Diseases