Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum
- Conditions
- Rectal Cancer
- Interventions
- Drug: Verdye Green
- Registration Number
- NCT05263336
- Lead Sponsor
- Jagiellonian University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- operative rectal cancer
- known allergy toward indocyanic green
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Verdye Green Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
- Primary Outcome Measures
Name Time Method Anastomotic leak 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 Outcome Measures
Name Time Method Postsurgical Ileus Up to 10 days post surgery Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery
Trial Locations
- Locations (1)
St John Grande Hospital
🇵🇱Kraków, Lesser Poland, Poland