Actively Recruiting
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
Led by University Hospital, Clermont-Ferrand · Updated on 2024-09-23
90
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hysterectomy is one of the most common surgical procedures in gynecology, especially by laparoscopy. Post-operative complications of hysterectomy are numerous and their causes are poorly understood. Indocyanine green is a fluorescent dye that, when exposed to infrared light, makes it possible to visualize the vascularization by fluorescence. The project consists in studying the vascularization of the vaginal cuff after total laparoscopic hysterectomy using the injection of indocyanine green. This is a prospective feasibility study. During the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence. The fluorescence values will be compared to the occurrence or absence of postoperative complications. This is the first study using this imaging technique combined with indocyanine green in this surgery. This study will employ a novel objective sequential fluorescence analysis software that has already proven its effectiveness in digestive surgery. The sequential measurement of the change in fluorescence intensity visualized in the images of laparoscopy will enable the production of vaginal perfusion graphs using a video modeling tool such as the TRACKER software. This software measures the evolution of green levels in a region of interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by a fluorescence intensity value of Fmax-Fmin on the graph.
CONDITIONS
Official Title
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient
- Scheduled for total hysterectomy by laparoscopic surgery
- Able to provide informed consent to participate
- Covered by the Social Security system
You will not qualify if you...
- Under guardianship, curatorship, or legal protection
- Refusal or inability to understand French
- Known allergy to iodine
- Currently pregnant or breastfeeding
- Procedure requires the use of indocyanine green
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise Laclautre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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