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The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
NCT02598414 · Acibadem University · Updated 24 Nov 2015
- What is being tested
- Near-infrared ICG fluorescence imaging; Traditional bowel anastomosis; FireFly™
- For
- Colon Neoplasms; Rectal Neoplasms; Inflammatory Bowel Disease; Diverticular Disease
- Kind of study
- Tests a treatment or device on volunteers. Phase 2 and Phase 3.
- Who can join
- Ages 18 years and older. About 102 people. The full rules are on the registry page.
- Where
- Turkey (Türkiye)
- When
- Starts or started Nov 2015, ends Dec 2017. Registered 5 Nov 2015.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Acibadem UniversityIstanbul, Turkey (Türkiye)
