Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 60
- 主要终点
- Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
研究概览
简要总结
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
详细描述
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patient hospitalized for a planned radical prostatectomy
排除标准
- •Consent refusal from the patient
- •Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique)
- •Absence of a French Health Care Insurance coverage
研究组 & 干预措施
robot-assisted laparoscopy
radical prostatectomy performed by robot-assisted laparoscopy
干预措施: assessment of urinary function and erectil function before and after prostatectomy (Other)
conventional laparoscopy
radical prostatectomy performed by conventional laparoscopy
干预措施: assessment of urinary function and erectil function before and after prostatectomy (Other)
laparotomy
radical prostatectomy performed by laparotomy
干预措施: assessment of urinary function and erectil function before and after prostatectomy (Other)
结局指标
主要结局
Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
时间窗: 45 Days after the surgery
Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite)
次要结局
- Prostate Specific Antigen (PSA) level(up to 5 years)
- impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score(45 Days after the surgery)
- impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score(upt to 5 years after the surgery)
- Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score(12 months)
- Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )(3 years)
- Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )(5 years)
- impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE(up to 5 years after surgery)