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临床试验/NCT01578356
NCT01578356已完成不适用

Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Biochemical recurrence at follow-up

研究概览

简要总结

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • prostate cancer
  • radical retropubic prostatectomy or
  • robot-assisted laparoscopic surgery

排除标准

  • 未提供

结局指标

主要结局

Biochemical recurrence at follow-up

时间窗: 6 months after prostatectomy

PSA measurement in the serum should not be \> or = 0,20 ng/ml.

Biochemical recurrence at follow-up.

时间窗: 6-monthly follow up between 1 and 5 years after prostatectomy.

PSA measurement in the serum should not be \> or = 0,20 ng/ml.

次要结局

  • Functional assessment concerning potency.(after 1, 3, 12 and 24 months)
  • Functional assessment concerning continence.(after 1, 3, 12 and 24 months)
  • Functional assessment concerning quality of life.(after 1, 3, 12 and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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