A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
Overview
- Phase
- Phase 3
- Sponsor
- Leiden University Medical Center
- Enrollment
- 978
- Locations
- 1
- Primary Endpoint
- 90-days Anastomotic Leakage (AL) rate
Overview
Brief Summary
Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- •Patients aged over 18 years old;
- •Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- •Signed informed consent prior to any study-mandated procedure;
Exclusion Criteria
- •Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- •Severe liver or kidney insufficiency;
- •Hyperthyroidism or a benign thyroid tumour;
- •Pregnant or breastfeeding women;
- •Scheduled for palliative surgery or terminal ill
- •Scheduled for a diverting stoma
- •Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
- •Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- •Emergency surgery
Arms & Interventions
Image Guided Bowel Anastomosis group
ICG-guided perfusion assessment
Intervention: ICG-guided bowel perfusion assessment (Drug)
Outcomes
Primary Outcomes
90-days Anastomotic Leakage (AL) rate
Time Frame: 90 days
Anastomotic leakage rate
Secondary Outcomes
- days in hospital stay(90 days)
- mortality(90 days)
- complication rate(90 days)
- 30-days Anastomotic Leakage ( AL) rate(30 days)
Investigators
Alexander Vahrmeijer
Principal Investigator
Leiden University Medical Center