Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- assessment of Kymerax systemerax
研究概览
简要总结
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.
Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.
Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.
Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient requiring a following surgical procedure realized usually by coelioscopy:
- •Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis
排除标准
- •Patient refusing to participate in the study
- •Patient understanding French.
- •Minor waits
研究组 & 干预措施
Surgical procedure with the system Kymerax
干预措施: Surgical procedure with the system Kymerax (Procedure)
Surgical procedure with the system Kymerax
干预措施: The system Kymerax (Device)
结局指标
主要结局
assessment of Kymerax systemerax
时间窗: 18 months
次要结局
未报告次要终点