Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

Jagiellonian University

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Drug: Verdye Green

Study type: Interventional

Funder types: Other

Identifiers

NCT05263336

ICG UJ Krakow

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• operative rectal cancer

Exclusion criteria

• known allergy toward indocyanic green

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Intraoperative verdye green iv administration to visualize blood supply to the anastomosis

Treatment:

Drug: Verdye Green

Control

No Intervention group

Description:

No administration of verdye green intraoperatively