Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Vadim Kuznetsov
- Enrollment
- 1,268
- Locations
- 1
- Primary Endpoint
- 30-days Anastomotic Leakage (AL) rate
Overview
Brief Summary
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.
An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.
Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Intraoperative imaging cannot blind the surgeon. The patient is only blinded prior to surgery.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged over 18 years old
- •ECOG status 0-2
- •Written informed consent
- •histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
- •Scheduled for colorectal resection with primary anastomosis
Exclusion Criteria
- •Pregnancy or breast feeding
- •Colon obstruction, perforation or bleeding complicating the tumor
- •Medical contraindications for surgical treatment
- •Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Arms & Interventions
The ICG group
The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.
Intervention: ICG-guided bowel perfusion assessment (Drug)
The control group
The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
Intervention: Conventional Bowel Anastomosis group (Other)
Outcomes
Primary Outcomes
30-days Anastomotic Leakage (AL) rate
Time Frame: 30-days
Anastomotic leakage rate
Secondary Outcomes
- complication rate(30-days)
- mortality(30-days)
- days in hospital stay(90-days)
Investigators
Vadim Kuznetsov
The doctor is a researcher
the BELOOSTROV Clinic of High Technologies