Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Intraoperative estimated bool loss
研究概览
简要总结
Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities.
The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients.
Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during 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
- Treatment
- 盲法
- None
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
- •male patients, aged 18-80 years
- •patients willing and able to provide written informed consent
- •voluntary partecipation
- •clinical indication to robot-assisted radical prostatectomy
排除标准
- •coagulation impairment at the time of surgery
- •salvage radical prostatectomy
结局指标
主要结局
Intraoperative estimated bool loss
时间窗: intraoperative
次要结局
- Overall positive surgical marigins(intraoperative)
- Apical positive surgicals margins(intraoperative)
- Transfusion rate(30 days from surgery)
- 1-month continence(30 days from surgery)
- 1-month PSA(30 days from surgery)
研究者
Alessandro Antonelli
Dirigente medico
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia