Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- time-sparing for bowel resection
研究概览
简要总结
Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology
详细描述
Using CAIMAN® technology in primary surgery for advanced ovarian cancer including bowel resections.
Analyze potential time-sparing and the incidence of post-surgical complications.
Prospective, longitudinal, observational. 40 patients / year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≤ 75 years
- •Patients with advanced ovarian cancer (FIGO stage IIIC-IV).
- •Bowel resection
- •Class 0-2 according to the American Society of Anesthesiologists (i.e.: ASA score ≤ 2)
- •Written informed consent to the study
排除标准
- •Pregnant or chronic infections
- •Previous pelvic radiotherapy
研究组 & 干预措施
Caiman device
Time sparing and post-operative outcome in ovarian cancer including bowel resection for cytoreductive surgery with Caiman device
干预措施: Caiman® device (Device)
结局指标
主要结局
time-sparing for bowel resection
时间窗: up to 1 hour
Time needed for bowel resection and radical omentecomy in avanced ovarian cancer
Post surgical complications
时间窗: Up to 6 months
F-up in 1-3 and 6 months with questionnaire
次要结局
未报告次要终点
研究者
Prof. Giovanni Scambia
Director
Catholic University of the Sacred Heart