Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
研究概览
简要总结
The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.
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
- •Minimum age of 18 Years
- •Voluntarily agreement to participate in this study
- •Written informed-consent
- •Release of medical records for regulatory or research purposes
- •Clinically organ-confined prostate cancer
排除标准
- •History of catheterization
- •History of radiation
- •History of chemotherapy
- •Person's participating in any other research
- •Unable to provide informed consent
结局指标
主要结局
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
时间窗: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening
To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery)
次要结局
- Number of patients with bacteriuria(5th day after the surgery)
研究者
J.H. Witt
MD.
St. Antonius Hospital Gronau