Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient

• Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.

• Patiente capable of providing informed consent to participate in the study.

• Patiente covered by the Social Security system.

Locations
Other Locations
France
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
+33 4 73 75 11 95
Time Frame
Start Date: 2024-09-21
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 90
Treatments
Other: Totale hysterectomy with indocyanine green and fluorescence intensity analysis
Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.~The difference from standard care is that during the intraoperative period, at the end of the procedure, the patient will receive a diluted bolus of indocyanine green. The collected images will be analyzed using the TRACKER software in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0).
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov