NCT01365143终止4 期
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Trifecta
研究概览
简要总结
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the prostate
- •Deemed a surgical candidate for a bilateral nerve bundle preservation
- •Continent of urine
- •Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
排除标准
- •Previous treatment of prostate cancer (radiation, hormones, etc.)
研究组 & 干预措施
Open Radical Prostatectomy
Active Comparator
干预措施: Open Radical Prostatectomy (Procedure)
Robotic radical prostatectomy
Active Comparator
干预措施: Robotic Radical Prostatectomy (Procedure)
结局指标
主要结局
Trifecta
时间窗: at 2 years
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy
次要结局
- Operative time(Participants will be followed for the duration of the operation, an expected average of 3 hours)
- Length of hospital stay(Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days)
- Continence(at 3, 12, and 24 months)
- Free from biochemical recurrence(at 3, 12, and 24 months)
- Acute complications(Within 30 days of surgery)
- Long-term complication(>30 days)
- Estimated blood loss(Participants will be followed for the duration of the operation, an expected average of 3 hours)
- Potency(at 3, 12, and 24 months)
研究者
研究点 (1)
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