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The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Acibadem Atakent University Hospital
Information provided by (Responsible Party):
Acibadem University

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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™).
Other Names:
  • Near-infrared fluorescence imaging
  • Indocyanine green

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.




Primary Outcome Measures :
  1. Anastomotic leak rate [ Time Frame: Postoperative 30 days ]
    Anastomotic leak rate within 30 post operative days


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: Postoperative 30 days ]
    Complication rate within postoperative 30 days

  2. Mortality [ Time Frame: Postoperative 30 days ]
    Mortality within 30 post operative days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Volkan Ozben, MD +905346484678 volkanozben@yahoo.co.uk

Locations
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Turkey
Acibadem University Recruiting
İstanbul, Turkey
Contact: norgaz, MD       tnorgaz@yahoo.com   
Principal Investigator: Ali Buturak, MD         
Sponsors and Collaborators
Acibadem University
Acibadem Atakent University Hospital
Investigators
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Principal Investigator: Bilgi Baca, MD,Prof.Dr. Department of General Surgery, Acibadem University, Atakent Hospital
Publications of Results:
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Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT02598414    
Other Study ID Numbers: ICG-COLORECTAL
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by Acibadem University:
Colorectal Disease
Robotic Surgery
Indocyanine Green Fluorescence Imaging
Anastomotic Leak
Short-term Outcomes
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Inflammatory Bowel Diseases
Anastomotic Leak
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Postoperative Complications
Pathologic Processes
Intraabdominal Infections
Infection
Pathological Conditions, Anatomical
Colonic Diseases
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs