Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Erectile function
研究概览
简要总结
Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively.
Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.
The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.
详细描述
180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened.
After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Localized prostate cancer
- •Planned nerve-sparing robotic radical prostatectomy
- •Gleason score 7 or less
排除标准
- •Previous prostate surgery (TURP, TUIP, laser...)
- •Planned lymphadenectomy
- •T3 cancer
研究组 & 干预措施
Preservation (endopelvic fascia)
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.
干预措施: Preservation (endopelvic fascia) (Procedure)
Opening (endopelvic fascia)
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.
干预措施: Opening (endopelvic fascia) (Procedure)
结局指标
主要结局
Erectile function
时间窗: 1 year
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Urinary incontinence
时间窗: 1 year
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
次要结局
- Complications(1 year)
- Oncologic results: positive surgical margin rate(1 year)