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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02598414
• Date of registration: 02/11/2015
• Prospective Registration: No
• Primary sponsor: Acibadem University
• Public title: The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
• Scientific title: The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
• Date of first enrolment: November 2015
• Target sample size: 102
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02598414
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Turkey

Contacts

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

• Name: Volkan Ozben, MD

• Name: norgaz, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Diverticular Disease

Colon Neoplasms

Rectal Neoplasms

Intervention(s)

Procedure: Near-infrared ICG fluorescence imaging

Procedure: Traditional bowel anastomosis

Device: FireFly™

Primary Outcome(s)

Anastomotic leak rate [Time Frame: Postoperative 30 days]

Secondary Outcome(s)

Mortality [Time Frame: Postoperative 30 days]

Complication rate [Time Frame: Postoperative 30 days]

Secondary ID(s)

ICG-COLORECTAL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Acibadem Atakent University Hospital