Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Urinary leakage measured by pad test in grams
研究概览
简要总结
The purpose of the study is to determine, whether the postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. Another finding could be the study of the pain assessment of the patient, as well as the pain medication at the various derivatives. Further check whether infections and the presence of bacteriuria can be reduced or avoided by the form of urinary drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •filled in and signed Informed Consent
- •release of medical records for regulatory or research purposes
- •clinically organ-confined prostate cancer
- •recommended and planned robot-assisted radical prostatectomy
排除标准
- •Participation in other interventional trials that could interfere with the present study
- •International Prostate Symptom Score (IPPS) > 18
- •History of radiation or chemotherapy
- •History of transurethral prostate resection
- •unable to provide informed consent
- •unwillingness to storage and forwarding of pseudonymous data
研究组 & 干预措施
suprapubic tube ex 2 day
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery
干预措施: suprapubic tube ex 2 day (Device)
suprapubic tube ex 5 day
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery
干预措施: suprapubic tube ex 5 day (Device)
transurethral catheter ex 5 day
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery
干预措施: transurethral catheter ex 5 day (Device)
结局指标
主要结局
Urinary leakage measured by pad test in grams
时间窗: within the day 2 or day 5 after the surgery for 24 hours
次要结局
- Recording of complications(within the 4 weeks after surgery)
- Residual urine measured by bladder scan in ml(3 times within the day 2 or day 5 after the surgery)
- Urine status measured by flow cytometry(within the day 2 or day 5 after the surgery)
- Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)(once a day, first 7 days after the surgery)