Clinical trial NCT06608082: Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
Official title: Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysterectomy
Vascularization
Complication of Surgical Procedure
Keywords: indocyanine green
laparoscopic hysterectomy
Post-operative complications of hysterectomy
TRACKER software
imaging technique
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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.

Detailed description: To perform this study, the patient will undergo a preoperative consultation with a senior surgeon and an anesthetist from the department to schedule the surgical procedure and discuss potential inclusion in the protocol.

Day before the surgery : The patient will give an informed and written consent and will be enrolled in the study.

The day of the intervention : The planned surgical procedure will be performed as initially scheduled by the surgeon (total hysterectomy). 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 (25 mg in 10 ml of 5% glucose solution), at a dose of 0.2 mg/kg. Subsequently, the laparoscopic camera system will be switched to an infrared camera system to visualize intra-abdominal fluorescence using the trocars used during the surgery. A video recording sequence of the vaginal cuff, lasting two to five minutes, starting from the moment of the indocyanine green injection will be collected by the investigator. The collected images will be analyzed using the TRACKER software (Douglas Brown, Open Source Physics, Boston MA, USA).

Postoperative period : A postoperative consultation will take place between 3 and 8 weeks after the surgery with one of the senior physicians from the department. Postoperative progress and early complications (dehiscence, cuff infection, abscess, or hematoma) will be documented, along with anatomopathological examination data and the final diagnosis.

The postoperative follow-up will remain consistent with the usual protocol following this procedure. The protocol does not involve any additional visits, thus no potential extra coast.

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.

Primary outcomes:
measure: 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).
timeFrame: 2 months
Secondary outcomes:
measure: Examine the different parameters derived from the perfusion curve.
timeFrame: 2 months
measure: Compare the objective fluorescence measurements to the surgeon's assessment.
timeFrame: through study completion, an average of 1 year
measure: Evaluate the immediate or delayed tolerance of indocyanine green.
timeFrame: through study completion, an average of 1 year
measure: Assess the additional time added to the total operative duration by the protocol.
timeFrame: 2 months
measure: Compare the vascularization of the vaginal cuff to patient characteristics.
timeFrame: 2 months
measure: Compare the vascularization of the vaginal cuff to Surgical technique
timeFrame: 2 months
measure: Compare the vascularization of the vaginal cuff to Type of camera
timeFrame: 2 months
measure: Compare the vascularization of the vaginal cuff to Post-operative complications
timeFrame: 2 months
measure: Compare the vascularization of the vaginal cuff to State of the vaginal cuff
timeFrame: 2 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: