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

Acibadem University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diverticular Disease; Inflammatory Bowel Disease; Colon Neoplasms; Rectal Neoplasms

Treatments: Procedure: Traditional bowel anastomosis; Device: FireFly™; Procedure: Near-infrared ICG fluorescence imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02598414

ICG-COLORECTAL

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Bowel Anastomosis Under ICG Guidance

Experimental group

Description:

Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.

Treatment:

Procedure: Near-infrared ICG fluorescence imaging

Device: FireFly™

Standard Bowel Anastomosis

Active Comparator group

Description:

Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.

Treatment:

Procedure: Traditional bowel anastomosis