A Prospective, Randomized Controlled Study Comparing the Integrated Posterior-Anterior-Lateral (PAL) Approach and the Posterior Approach in Robot-Assisted Radical Prostatectomy: Evaluation of Perioperative Outcomes, Postoperative Functional Recovery, and Oncologic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- urinary continence
研究概览
简要总结
This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was:
What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate biopsy confirms prostate cancer;
- •Clinical T stage <=T3a stage;
- •Fully understand clinical trial protocols and sign informed consent;
排除标准
- •Urinary incontinence before surgery;
- •Previous endoscopic prostate surgery;
- •There are serious underlying diseases that cannot tolerate surgery or have a survival of less than 5 years;
- •Metastatic disease is present or lymph node involvement is suspected at diagnosis;
- •Patients judged by the investigator to be unsuitable for participation in this clinical trial;
结局指标
主要结局
urinary continence
时间窗: Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months.
was defined as the use of zero to one safety pad per day without any involuntary leakage.Immediate continence was defined as continence within seven days after catheter removal, while early continence was defined as continence achieved within three months.
次要结局
- Operation time(During operation)
- Estimated blood loss(During operation)
- Complications(Perioperative)
- Time for removal of drainage tube(Perioperative)
研究者
Xuepei Zhang
Director of Urology
The First Affiliated Hospital of Zhengzhou University