The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
1 other identifier
interventional
102
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 24, 2015
November 1, 2015
2.1 years
November 2, 2015
November 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leak rate
Anastomotic leak rate within 30 post operative days
Postoperative 30 days
Secondary Outcomes (2)
Complication rate
Postoperative 30 days
Mortality
Postoperative 30 days
Study Arms (2)
Bowel Anastomosis Under ICG Guidance
EXPERIMENTALPatients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
Standard Bowel Anastomosis
ACTIVE COMPARATORPatients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.
Interventions
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 will be performed without ICG fluorescence imaging.
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Eligibility Criteria
You may qualify if:
- Subject is able to give informed consent for participation in the study
- 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
You may not qualify if:
- Subjects present with bowel obstruction or perforation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acibadem Universitylead
- Acibadem Atakent University Hospitalcollaborator
Study Sites (1)
Acibadem University
Istanbul, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 24566744RESULTJafari 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.
PMID: 25451666RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bilgi Baca, MD,Prof.Dr.
Department of General Surgery, Acibadem University, Atakent Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 5, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 24, 2015
Record last verified: 2015-11