Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
研究概览
简要总结
Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.
Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.
详细描述
Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.
Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.
After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laparoscopic surgery for endometriosis
- •informed consent to participate in the study
排除标准
- •known or suspected allergy to iodide
- •history of active pelvic infection
- •presence of intra-abdominal or pelvic malignancy
- •pelvic radiation therapy
- •hyperthyroidism
- •liver dysfunction
- •serum creatinine > 2.0 mg/dL
结局指标
主要结局
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
时间窗: From the surgery time, assessed up to 7 days after surgery
Evaluation of feasibility and safety of indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis, considering complications using Clavien-Dindo Classification (from Grade I to V)
次要结局
- Ureteral vascularization(Intraoperative)
研究者
Renato Seracchioli
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna