The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

Study Overview
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Brief Summary
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In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time. Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.

Official Title
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The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial

Conditions
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Colon Neoplasms, Rectal Neoplasms, Inflammatory Bowel Disease, Diverticular Disease

Intervention / Treatment
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* Procedure: Near-infrared ICG fluorescence imaging
* Procedure: Traditional bowel anastomosis
* Device: FireFly™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to give informed consent for participation in the study Subject is willing and able to comply with the study procedures Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision Subject is scheduled for robotic colon or rectal resection A negative pregnancy test for women of childbearing potential prior to surgery Exclusion Criteria: Subjects present with bowel obstruction or perforation Subject undergo emergency surgery Subject with ASA IV, V History of allergy or hypersensitivity against indocyanine green Pregnant or breast-feeding women Subject has uremia (serum creatinine >2.5 mg/dl) Subject is undergoing palliative surgery or who is terminally ill Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bowel Anastomosis Under ICG Guidance<br>Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging. | Procedure: Near-infrared ICG fluorescence imaging<br>* Patient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).<br>* Other names: Indocyanine green;Device: FireFly™<br>* The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).<br>|
| Active Comparator: Standard Bowel Anastomosis<br>Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging. | Procedure: Traditional bowel anastomosis<br>* Traditional bowel anastomosis will be performed without ICG fluorescence imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak rate | Anastomotic leak rate within 30 post operative days | Postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Complication rate within postoperative 30 days | Postoperative 30 days | 
| Mortality | Mortality within 30 post operative days | Postoperative 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Disease, Robotic Surgery, Indocyanine Green Fluorescence Imaging, Anastomotic Leak, Short-term Outcomes