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

NCT06608082 | Recruiting

• 1 other identifier: AOI 2023 CHAUVET
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy; Vascularization; Complication of Surgical Procedure

Keywords

indocyanine green; laparoscopic hysterectomy; Post-operative complications of hysterectomy; TRACKER software; imaging technique

Outcome Measures

Primary Outcomes (1)

• Study the presence of indocyanine green in the vaginal cuff during the total laparoscopic hysterectomy, in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0).

  An objective measurement of fluorescence will be employed. Sequential measurement of fluorescence intensity changes observed in the laparoscopy images will enable the creation of vaginal perfusion graphs using a video modeling tool like the TRACKER software (Douglas Brown, Open Source Physics, Boston MA, USA). This software tracks the evolution of green levels within a region of interest, from which a time-fluorescence curve can be derived. The presence of fluorescence will be defined by the fluorescence intensity value Fmax-Fmin. All procedures will be recorded and subsequently collected by the investigator. All collected images will undergo analysis using the TRACKER software (Douglas Brown, Open Source Physics, Boston MA, USA).

  2 months

Secondary Outcomes (9)

• Examine the different parameters derived from the perfusion curve.

  2 months

• Compare the objective fluorescence measurements to the surgeon's assessment.

  through study completion, an average of 1 year

• Evaluate the immediate or delayed tolerance of indocyanine green.

  through study completion, an average of 1 year

• Assess the additional time added to the total operative duration by the protocol.

  2 months

• Compare the vascularization of the vaginal cuff to patient characteristics.

  2 months

Study Arms (1)

Totale hysterectomy with indocyanine green and fluorescence intensity analysis

OTHER

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).

Diagnostic Test: indocyanine green injected intravenously

Interventions

indocyanine green injected intravenously DIAGNOSTIC_TEST

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.

Totale hysterectomy with indocyanine green and fluorescence intensity analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study the presence of indocyanine green in the vaginal cuff during the total laparoscopic hysterectomy, in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0). This is a prospective feasibility study

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 23, 2024
• Study Start: September 21, 2024
• Primary Completion: March 31, 2025
• Study Completion: November 30, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)