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

J

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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