Evaluation of the Safety of Intraperitoneal Laparoscopic Radical Prostatectomy With or Without Drainage Tube: a Singlecentre, Randomised Controlled, and Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The rate of adverse event
研究概览
简要总结
This is a randomized controlled and non-inferiority trial in comparison of intraperitoneal laparoscopic radical prostatectomy without drainage tube between intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.
详细描述
This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men with localized prostate cancer. This study aims to determine whether intraperitoneal laparoscopic radical prostatectomy without drainage tube is non-inferior to intraperitoneal laparoscopic radical prostatectomy with drainage tube in the safety in men with a localized prostate cancer.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age: more than 18 years old, less than 85 years old;
- •Patient who pathologically diagnosed with prostate cancer and plan to undergo radical laparoscopic surgery for prostate cancer;
- •fully understand the clinical trial protocol and sign the informed consent;
排除标准
- •patients with surgical contraindications who cannot accept surgery;
- •patients with non-laparoscopic radical resection of prostate cancer;
- •patients with previous pelvic radiation therapy and complicated abdominal surgery;
- •patients judged by the investigator to be unsuitable to participate in the clinical trial;
结局指标
主要结局
The rate of adverse event
时间窗: 3 month
Any adverse event according to the Clavien-Dindo classification will be recorded
次要结局
- Intestinal function recovery(3 Months)
- Hemoglobin(3 Months)
- Abdominal effusion and cyst(3 Months)
- Physical recovery(3 Months)