Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Upstaging rate
研究概览
简要总结
Prospective multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).
详细描述
This multicentric prospective randomized Phase III trial is aimed to verify if the use of uterine manipulator for laparoscopic/robotic treatment of early stage endometrial cancer can influence the impact of peritoneal cytology and lymph vascular space invasion (LVSI) and the outcomes in terms of perioperative and oncological (disease free survival - DFS, overall survival - OS) outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For patients
- •Age > 18 < 80 years
- •Patient's informed consent
- •American Society of Anesthesiologists: < class III or IV
- •No actual pregnancies
- •Body Mass Index (BMI) ≤ 35
- •For diseases
- •Early stage endometrial cancer (IA-IB)
- •Endometrioid histotype (G1-G2)
排除标准
- •For patients
- •Age > 18 < 80
- •Actual pregnancies
- •Previous gynecological cancer
- •For disease
- •Type II endometrial cancer histotype
- •Grade 3 endometrial cancer
- •Advanced stage endometrial cancer (II - IV)
- •Previous radiotherapy on the pelvic field
- •Uterine size larger than conform 12 weeks gestation or 9 cm in horizontal
- •Necessity of laparotomic procedures
结局指标
主要结局
Upstaging rate
时间窗: 30 days
Evaluation of Lymphovascular space invasion and pre- / post-Hysterectomy pelvic cytology in order to investigate if the use of uterine manipulator has a role in upstaging of early-stage endometrial cancer
次要结局
- Blood Loss(Intraoperative)
- Complications(within 30 days from surgery)
- Impact on postoperative pain(Postoperative)
- Impact of surgical procedure(Perioperative)
- Role of uterine manipulator in Obesity(Intraoperative)
- Oncological Outcomes: Rate of local relapses(1 years - 5 years)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart