The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Anastomotic leak
Study Overview
Brief Summary
The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •operative rectal cancer
Exclusion Criteria
- •known allergy toward indocyanic green
Arms & Interventions
Intervention
Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
Intervention: Verdye Green (Drug)
Outcomes
Primary Outcomes
Anastomotic leak
Time Frame: Up to two weeks post surgery
Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line
Secondary Outcomes
- Postsurgical Ileus(Up to 10 days post surgery)
Investigators
Paweł Bogacki
Principle Investigator
Jagiellonian University