A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial) (FLAG)
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|ClinicalTrials.gov Identifier: NCT03390517|
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer Sigmoid Cancer||Device: Fluorescence angiography with indocianyne green||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- Anastomotic Leak Rate [ Time Frame: 0 to 30 days ]
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
|Contact: Evgeny Rybakov, Dr.Med.Sc.||+7 499 199 firstname.lastname@example.org|
|State Scientific Centre of Coloproctology||Recruiting|
|Moscow, Russian Federation, 123423|