Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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).
时间窗: 2 months
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).
次要结局
- 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)
- Compare the vascularization of the vaginal cuff to Surgical technique(2 months)
- Compare the vascularization of the vaginal cuff to Type of camera(2 months)
- Compare the vascularization of the vaginal cuff to Post-operative complications(2 months)
- Compare the vascularization of the vaginal cuff to State of the vaginal cuff(2 months)