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

Summary

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.

Conditions

• Colon Neoplasms
• Rectal Neoplasms
• Inflammatory Bowel Disease
• Diverticular Disease

Interventions

PROCEDURE

Near-infrared ICG fluorescence imaging

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™).

PROCEDURE

Traditional bowel anastomosis

Traditional bowel anastomosis will be performed without ICG fluorescence imaging.

DEVICE

FireFly™

The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).

Sponsors & Collaborators

• Acibadem Atakent University Hospital

  collaborator OTHER

• Acibadem University

  lead OTHER

Principal Investigators

• Bilgi Baca, MD,Prof.Dr. · Department of General Surgery, Acibadem University, Atakent Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Turkey (Türkiye)

Study Locations