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

November 22, 2015 updated by: Acibadem University

The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Recruiting
        • Acibadem University
        • Contact:
        • Principal Investigator:
          • Ali Buturak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:
  • Indocyanine green
  • Near-infrared 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leak rate
Time Frame: Postoperative 30 days
Anastomotic leak rate within 30 post operative days
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: Postoperative 30 days
Complication rate within postoperative 30 days
Postoperative 30 days
Mortality
Time Frame: Postoperative 30 days
Mortality within 30 post operative days
Postoperative 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

Acibadem Atakent University Hospital

Investigators

  • Principal Investigator: Bilgi Baca, MD,Prof.Dr., Department of General Surgery, Acibadem University, Atakent Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (ESTIMATE)

November 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG-COLORECTAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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