The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT02598414|
Recruitment Status : Unknown
Verified November 2015 by Acibadem University.
Recruitment status was: Recruiting
First Posted : November 5, 2015
Last Update Posted : November 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Neoplasms Rectal Neoplasms Inflammatory Bowel Disease Diverticular Disease||Procedure: Near-infrared ICG fluorescence imaging Procedure: Traditional bowel anastomosis Device: FireFly™||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Bowel Anastomosis Under ICG Guidance
Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
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™).
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Active Comparator: Standard Bowel Anastomosis
Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.
Procedure: Traditional bowel anastomosis
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
- Anastomotic leak rate [ Time Frame: Postoperative 30 days ]Anastomotic leak rate within 30 post operative days
- Complication rate [ Time Frame: Postoperative 30 days ]Complication rate within postoperative 30 days
- Mortality [ Time Frame: Postoperative 30 days ]Mortality within 30 post operative days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598414
|Contact: Volkan Ozben, MDfirstname.lastname@example.org|
|Contact: norgaz, MD email@example.com|
|Principal Investigator: Ali Buturak, MD|
|Principal Investigator:||Bilgi Baca, MD,Prof.Dr.||Department of General Surgery, Acibadem University, Atakent Hospital|