The Use of Indocyanine Green-Based Fluorescence Imaging for Intraoperative Detection of Peritoneal Endometriosis

Completed

• Conditions: endometriosis; 10029903

• Registration Number: NL-OMON47083
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

In order to be eligible to participate in this study, a patient must meet all of the following criteria:
Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected or proven
Able to understand the nature of the study and what will be required of them
Females
Age >18years
Premenopausal
No history of impaired liver and renal function
No history of hypersensitivity or allergy to indocyanine green
Willing to participate

Exclusion Criteria

Not able to give written informed consent
Males
Aged < 18 years
Pregnant or breast-feeding women
Known indocyanine green hypersensitivity or allergy
Not willing to participate

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: Investigate the feasibility of identification<br /><br>of endometriotic lesions with (conventional non-robotic) fluorescence<br /><br>laparoscopy equipment with preoperative or peroperative ICG administration.<br /><br>Assessment will be performed using an intraoperative registration form (see<br /><br>attachment), postoperative video-analysis (with determination of the<br /><br>target-to-background ratio) and with histological confirmation. Biopsies will<br /><br>be taken from suspicious endometriotic areas seen with both the conventional<br /><br>white light mode and NIRF-mode, areas that appear only with white light mode<br /><br>or NIRF-mode and areas without any visible or fluorescent areas. Histologic<br /><br>examination is carried out on the biopsies to confirm the diagnosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>