NCT02598414

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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™).

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-11-05
• Last updated: 2015-11-24

Locations

1 site across 1 country: Turkey (Türkiye)