Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 主要终点
- Overall survival.
研究概览
简要总结
Prospective controlled study (Canadian Task Force II-2) : Comparison analysis regarding surgical outcomes, complications, overall survival (OS), disease free survival (DFS) and cancer specific survival between patients subjected to radical Hysterectomy either by open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).
详细描述
Study Objective: To analyse the effect that the introduction of minimally invasive procedures has had on surgical and oncological outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer center Design: A prospective controlled study (Canadian Task Force II-2) Setting: A university teaching hospital Patients: All patients that underwent RH as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients.
Interventions: Patients underwent an open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
- •Subjected to Radical Hysterectomy.
排除标准
- •Pregnant women in which a RH was performed at the time of caesarean section.
- •Previous chemotherapy treatment
- •Previous pelvic radiotherapy
结局指标
主要结局
Overall survival.
时间窗: up to 240 months
From date of randomization until the date of death from any cause.
次要结局
- surgical complication Rate(up to 28 days)
- Disease free survival(up to 240 months)
- Cancer specific survival(up to 240 month)