The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
NCT ID: NCT02598414
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
102 participants
INTERVENTIONAL
2015-11-30
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bowel Anastomosis Under ICG Guidance
Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
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™).
FireFly™
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Standard Bowel Anastomosis
Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.
Traditional bowel anastomosis
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
Interventions
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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™).
Traditional bowel anastomosis
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
FireFly™
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Acibadem Atakent University Hospital
OTHER
Acibadem University
OTHER
Responsible Party
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Principal Investigators
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Bilgi Baca, MD,Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of General Surgery, Acibadem University, Atakent Hospital
Locations
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Acibadem University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Ris F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25.
Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28.
Other Identifiers
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ICG-COLORECTAL
Identifier Type: -
Identifier Source: org_study_id