Examining blood vessel formation in the vaginal area after laparoscopic hysterectomy using a special dye.
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study
This study is testing a special dye to see how well blood vessels form in the vaginal area after laparoscopic hysterectomy and if this affects recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06608082 on ClinicalTrials.gov |
What this trial studies
This study investigates the vascularization of the vaginal cuff following total laparoscopic hysterectomy by utilizing indocyanine green, a fluorescent dye. After the hysterectomy, the dye will be injected intravenously, and an infrared camera will capture fluorescence images of the vaginal cuff. These images will be analyzed using specialized software to quantify fluorescence levels, which will then be correlated with the occurrence of postoperative complications. This prospective feasibility study aims to enhance understanding of postoperative outcomes related to vascularization.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for total laparoscopic hysterectomy who can provide informed consent.
Not a fit: Patients with known allergies to iodine, ongoing pregnancy, or those requiring the use of indocyanine green will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and reduction of postoperative complications in patients undergoing laparoscopic hysterectomy.
How similar studies have performed: This approach is novel and has not been extensively tested in similar studies, making it a potentially groundbreaking investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33 4 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.