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

Jagiellonian University180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Rectal Cancer

Interventions

Verdye GreenDRUG

intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * operative rectal cancer Exclusion Criteria: * known allergy toward indocyanic green

Locations (1)

St John Grande Hospital

Krakow, Lesser Poland Voivodeship, Poland

RECRUITING

Outcomes

Primary Outcomes

Anastomotic leak

Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line

Time frame: Up to two weeks post surgery

Secondary Outcomes

Postsurgical Ileus

Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery

Time frame: Up to 10 days post surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.