Clinical trial NCT02598414: The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colon Neoplasms
Rectal Neoplasms
Inflammatory Bowel Disease
Diverticular Disease
Keywords: Colorectal Disease
Robotic Surgery
Indocyanine Green Fluorescence Imaging
Anastomotic Leak
Short-term Outcomes
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Acibadem Atakent University Hospital
First posted: 2015-11-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: Complication rate
timeFrame: Postoperative 30 days
measure: Mortality
timeFrame: Postoperative 30 days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Department of General Surgery, Acibadem University, Atakent Hospital
name: Bilgi Baca, MD,Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.