A Randomized Controlled Trial Evaluating the Impact of Small Versus Large Urethral Bites on Continence Outcomes After Robotic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Evaluating the impact of the urethral bites
研究概览
简要总结
To evaluate the impact of sustainable functional urethral reconstruction (SFUR) on early recovery of urinary continence (UC) after robot-assisted radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male patients aged 18 years and older.
- •Diagnosis of prostate cancer with an indication for robotic-assisted radical prostatectomy (RARP).
- •Ability to provide informed consent.
排除标准
- •History of pelvic radiation therapy
- •Prostatectomy performed in the context of salvage therapy (e.g., post-radiation or post-focal therapy)
- •Presence of extra-pelvic metastatic disease
- •Neurological disorders significantly affecting continence (e.g., severe Parkinson's disease, multiple sclerosis)
- •Pre-existing urinary incontinence
- •Inability to comply with follow-up protocols
研究组 & 干预措施
Small Bites
Patients will undergo Robotic-assisted radical prostatectomy (RARP) with vesicourethral anastomosis using small urethral bites, as determined by the surgeon, with goal of being approximately 5-7 mm from the cut edge of the urethra.
干预措施: Small Urethral Bite Technique (Procedure)
Large Bites
Patients will undergo Robotic-assisted radical prostatectomy (RARP) with vesicourethral anastomosis using large urethral bites, as determined by the surgeon, with goal of being approximately 15-20 mm from the cut edge of the urethra.
干预措施: Large Urethral Bite Technique (Procedure)
结局指标
主要结局
Evaluating the impact of the urethral bites
时间窗: 6 months following RARP
To evaluate the impact of small versus large urethral bites during vesicourethral anastomosis on urinary continence at 6 months following Robotic-assisted radical prostatectomy (RARP). Specifically, we aim to determine whether a smaller or larger suture bite technique results in superior continence recovery. This will be measured by comparing the number of incontinence pads that are needed to be used per day between each group.
次要结局
- Assessment of urinary leaks and complications(12 months following surgery)
- Assessment of urinary leaks and complications(3 months following surgery)