NCT00502723Unknown3 期
Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 1,440
- 试验地点
- 2
- 主要终点
- laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
研究概览
简要总结
National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
详细描述
The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, old patient of less than 70 years,
- •having a prostate cancer proven histologically, requiring a radical prostatectomy.
- •Clinical stage T1c and rate of PSA (with 20 ng/ml).
- •Osseous scintiscanning and abdomen-pelvic scanner negative.
- •Patient informed of the study and its participation.
- •Patient affiliated to a social security system.
排除标准
- •Contra-indication with the surgery or the anaesthesia.
- •Antecedent of prostate resection or adenomectomy.
- •Antecedent of inguinal hernia treatment.
- •Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
- •Patient privatized of freedom.
结局指标
主要结局
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
时间窗: during the study
次要结局
- Carcinological (percentage of positive surgical margins, percentage of capsular crossing).(after the surgical)
- Functional (urinary continence, sexuality, quality of life)(at 2 years)
- per and post operational morbidity(during the 36 months)
- economic(duration and cost of hospitalization)
研究者
研究点 (2)
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