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

NCT ID: NCT05263336

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-03

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Verdye Green

Intervention Type DRUG

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

Control

No administration of verdye green intraoperatively

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Verdye Green

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

Intervention Type DRUG

Other Intervention Names

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Indocyianic Green

Eligibility Criteria

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Inclusion Criteria

* operative rectal cancer

Exclusion Criteria

* known allergy toward indocyanic green
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Paweł Bogacki

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St John Grande Hospital

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Pawel Bogacki

Role: primary

0048667177677

Other Identifiers

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ICG UJ Krakow

Identifier Type: -

Identifier Source: org_study_id

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