NCT06608082 Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
| NCT ID | NCT06608082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Hysterectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-09-21 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-09-21 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Protected patient, under guardianship, curatorship or legal protection. * Patient's refusal or inadequate understanding of the French language. * Known allergy to iodine. * Ongoing pregnancy and breastfeeding. * Procedure requiring the use of indocyanine green.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06608082 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608082 currently recruiting?
Yes, NCT06608082 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT06608082 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT06608082 clinical trial?
NCT06608082 is sponsored by University Hospital, Clermont-Ferrand. The trial plans to enroll 90 participants.