Идёт набор NCT06608082

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

Без фазы С лечением Hysterectomy Vascularization Complication of Surgical Procedure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: indocyanine green injected intravenously.
Кому может быть актуально: Состояния в реестре: Hysterectomy, Vascularization, Complication of Surgical Procedure. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Диагностический тест indocyanine green injected intravenously
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.

Первичные конечные точки

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). [Срок оценки: 2 months]

Вторичные конечные точки (9)

Examine the different parameters derived from the perfusion curve. [Срок оценки: 2 months]
Compare the objective fluorescence measurements to the surgeon's assessment. [Срок оценки: through study completion, an average of 1 year]
Evaluate the immediate or delayed tolerance of indocyanine green. [Срок оценки: through study completion, an average of 1 year]
Assess the additional time added to the total operative duration by the protocol. [Срок оценки: 2 months]
Compare the vascularization of the vaginal cuff to patient characteristics. [Срок оценки: 2 months]
Compare the vascularization of the vaginal cuff to Surgical technique [Срок оценки: 2 months]
Compare the vascularization of the vaginal cuff to Type of camera [Срок оценки: 2 months]
Compare the vascularization of the vaginal cuff to Post-operative complications [Срок оценки: 2 months]
Compare the vascularization of the vaginal cuff to State of the vaginal cuff [Срок оценки: 2 months]

Критерии участия

Критерии включения

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.