Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Study Overview
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Brief Summary
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This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

Official Title
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Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

Conditions
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Colorectal Cancer, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Diverticulosis, Colonic, Gastrointestinal Disease

Intervention / Treatment
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* Device: ICG fluorescence imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study. Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold). Exclusion Criteria: Emergent patients Patients with proven diverticular abscess and colonic fistulas are excluded Patients with planned open surgery are excluded.

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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No

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 fluorescence imaging<br>Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging. | Device: ICG fluorescence imaging<br>* The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.<br>|
| No Intervention: Standard procedure<br>Standard colorectal surgery and anastomosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis leakage rate |  | 0 to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of anastomosis leakage | Grade A-C according to International Study Group of Rectal Cancer | 0 to 90 days | 
| Timing of anastomosis leakage | Days | 0 to 90 days | 
| Deep surgical site infections | Yes/no | 0 to 90 days | 
| Hospital readmission rate |  | 0 to 90 days | 
| Reoperation rate |  | 0 to 90 days | 
| 30- and 90-day complications according to Clavien-Dindo Classification | Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b. | 0 to 90 days | 
| Operation time | Time from the start of the operation until the surgeon has ended the operation | 0-600 minutes | 
| Length of hospital stay | Day of the operation is considered the day 0 | 0-365 days | 
| 30- and 90-day mortality |  | 0 to 90 days | 
| Time to first bowel movement | Postoperative day when the first bowel movement occurs | 0-30 days | 
| Time to first flatus | Postoperative day when the first flatus occurs | 0-30 days | 
| Hospital costs |  | 0 to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Anastomosis, Anastomosis leak, Fluorescence imaging