Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Fluorescence uptake or not at the area of cystectomy (binary criterion)
研究概览
简要总结
To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods.
详细描述
The study will be open to any patient meeting the inclusion / exclusion criteria, scheduled for intraperitoneal cystectomy or cyst destruction using Plasmajet, corresponding to a benign organic cyst requiring surgical treatment according to current recommendations.
It will proceed as follows:
- Recruitment of patients during the preoperative consultation. The information form will be given to the patient.
- The day before the intervention: Inclusion proposed to the patient after re-explanation of the objectives and the progress of the study, submission of the consent form for the patient to sign. Realization of an ultrasound with count of antral follicles, and description of the ovarian cyst (size, aspect, IOTA criteria). Performing a blood test with AMH measurement to assess the preoperative ovarian reserve.
- The day of the intervention: Intraoperative, injection at the end of the procedure of a bolus of indocyanine green intravenously. Studied through an infrared camera system - the SPIES system (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany) - fluorescence within the ovary will bring out the vascularization of the area of cystectomy or destruction of the cyst. Evaluation of the degree of fluorescence (between 0 and 4, on the model of a Likert scale) carried out at the area of cystectomy or destruction of the cyst. Then, the second evaluation technique using the METAMORPH software will assign a raw and objective score according to the fluorescence visualized. The 2 evaluation results will be compared with each other.
- Postoperatively: there will be no special clinical or biological monitoring. If undesirable effects related to Indocyanine Green occur, they will be noted.
- After discharge, as part of her standard follow-up for short-term desire for pregnancy: she will have a postoperative consultation planned 1 month after the intervention, followed by examination at 6 months and 12 months with an ultrasound for evaluation CFA and blood work with AMH.
Any natural pregnancy will be noted.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI).
- •Patient able to provide informed consent to her participation in the study.
- •Patient covered by the " Sécurité Social " insurance system.
排除标准
- •Adult patient under protection, tutorship or curatorship.
- •Refusal of the patient or poor understanding of the French language.
- •Known allergy to iodine.
- •Current pregnancy or breastfeeding
研究组 & 干预措施
Kysindo
Group of 45 patients with short-term desire for pregnancy who will undergo laparoscopic ovarian cystectomy with use of indocyanine green. Evaluation of the ovarian reserve preoperatively and longitudinal cohort follow-up after surgery at 6 months and 12 months. Analysis by a new imaging technique.
干预措施: Use of Indocyanine Green in laparoscopic ovarian cystectomy (Diagnostic Test)
结局指标
主要结局
Fluorescence uptake or not at the area of cystectomy (binary criterion)
时间窗: Inoperative
A fluorescence score based on a Likert scale will be used. The presence of fluorescence will correspond to a success, defined by a value on the scale strictly greater than 0. The absence of fluorescence will be a failure, defined as equal to 0. The judgment criterion will therefore be binary (fluorescence uptake or no at the area of cystectomy), allowing the feasibility judgement.
次要结局
- Added time(Immediate post operativ)
- METAMORPH Score(In immediate postoperative)
- Rate of Side Effects(In per and immediate postoperative)
- Number of Participants with Pregnancy(Month 12)
- AMH dosage(Month 12)
- Evaluation of the ovarian reserve by ultrasound by CFA(Month 12)