Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Residual tumor at the end of surgery (using the completeness of cytoreduction score)
研究概览
简要总结
To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.
详细描述
All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary Ovarian cancer
- •Epithelial histotype
- •Stage III-IV disease
排除标准
- •Anesthesiological contraindication to primary cytoreduction
- •Extension of disease contraindicating primary cytoreduction
结局指标
主要结局
Residual tumor at the end of surgery (using the completeness of cytoreduction score)
时间窗: June 2007 - July 2015
次要结局
- Overall Survival(June 2007 - July 2016)
- Disease-free Survival(June 2007 - July 2016)
研究者
Stefano Uccella
Doctor
Università degli Studi dell'Insubria
