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

The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05263336

Enrollment

180

Registered

2022-03-02

Start date

2021-01-03

Completion date

2023-12-31

Last updated

2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, laparoscopic anterior resection, intraoperative angiography, ICG

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.

Interventions

DRUGVerdye Green

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* operative rectal cancer

Exclusion criteria

* known allergy toward indocyanic green

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026