Colonic Neoplasms Malignant, Colo-rectal Cancer
Conditions
Keywords
ICG-guided quantitative assessment of bowel perfusion
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.
Interventions
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
OTHERConventional Bowel Anastomosis group
conventional perfusion assessment
Sponsors
Vadim Kuznetsov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Intraoperative imaging cannot blind the surgeon. The patient is only blinded prior to surgery.
Intervention model description
multicentre randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-days Anastomotic Leakage (AL) rate | 30-days | Anastomotic leakage rate |
Secondary
| Measure | Time frame |
|---|---|
| complication rate | 30-days |
| mortality | 30-days |
| days in hospital stay | 90-days |
Countries
Russia
Contacts
Primary ContactVadim Kuznetsov
Backup ContactTimur Lankov
Outcome results
None listed