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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Cancer, Sigmoid Cancer

Intervention / Treatment
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* Device: Fluorescence angiography with indocianyne green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG group<br>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<br>* 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.<br>|
| No Intervention: Standard<br>A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic Leak Rate |  | 0 to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluorescence angiography, indocyanine green, anastomotic leakage