Impact of Early Dorsal Venous Complex (eDVC) Ligation on Urinary Continence Recovery in Patients Undergoing Robot-assisted Radical Prostatectomy (RARP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Early urinary continence recovery
研究概览
简要总结
The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins.
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
- Single (Participant)
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 between 18 and 80 years old
- •Planned to receive robot-assisted radical prostatectomy for prostate cancer
- •Able to understand and willing to sign a written informed consent document
- •On stable dose of current regular medication for at least 4 weeks prior to trial entry
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •Life expectancy of less than 12 months
- •Previous chemotherapy
- •Previous brachytherapy or external beam radiotherapy
- •Preexisting urinary incontinence defined as 1 or more pads per day
- •Unstable cardiovascular disease
- •Congestive Heart Failure (CHF)
- •Clinically significant hepatobiliary or renal disease
- •History of significant CNS injuries within 6 months
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
研究组 & 干预措施
Group 1
During robot-assisted radical prostatectomy after the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The DVC will be identified and incised. The DVC will be then selectively ligated using a V-lok 3/0 barbed suture. After the early DVC isolation, incision and ligation, the bladder neck will be incised and preserved when possible. A posterior nerve sparing approach will be then performed. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.
干预措施: Early DVC ligation (Procedure)
Group 2
After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The bladder neck will be then incised and preserved when possible. An inter-fascial or intra-fascial nerve-sparing technique will be then performed and the posterolateral aspect of the neurovascular bundles will be preserved. The DVC will be then isolated and selectively ligated using a V-lok 3/0 barbed suture. The anterolateral fibers of the neurovascular bundles will be then identified and preserved when possible. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.
干预措施: Early DVC ligation (Procedure)
结局指标
主要结局
Early urinary continence recovery
时间窗: 4 weeks
Continence recovery evaluated with the ICIQ-SF questionnaire
次要结局
- Perioperative outcomes(30 days)
- Erectile function recovery(16 weeks)
- PSA persistence or biochemical recurrence(4, 16 and 48 weeks)
- Urinary continence recovery(16 weeks)
- Positive surgical margins(4 weeks)
研究者
Francesco Montorsi
MD, FRCS (Hon), Professor and Chairman, Department of Urology Vita e Salute San Raffaele University, Milan, Italy
IRCCS San Raffaele