Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Overall cost (€) of patient care
研究概览
简要总结
The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.
The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).
详细描述
The secondary objectives of this research are to compare the following between the two groups:
- The actual cost of the surgical prostatectomy.
- Erectile function at 0, 1, 6, 12 and 24
- Oncological results at 1, 6, 12 and 24 months.
- Functional results at 0, 1, 6, 12 and 24 months.
- Quality of life at 0, 1, 6, 12 and 24 months.
- Complication rates at 1 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 24 months of follow up
- •Patient has localised prostate cancer
- •Patient is eligible for radical prostatectomy
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Patient has a contraindication for a treatment necessary for this study
- •Patients with psychiatric disorders
结局指标
主要结局
Overall cost (€) of patient care
时间窗: 60 months
Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 5 years. All medical resources consumed will be evaluated during the first 5 years after surgery.
次要结局
- Presence/absence of complications (Pentafecta)(24 months)
- Change in function as estimated by the PR25 questionnaire(baseline to 24 months)
- Cost (€) of surgery via micro-costing(Day 1)
- Change in erectile function(baseline to 24 months)
- the % of positive margins after resection(baseline (Day 1))
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)(24 months)
- Change in quality of life as estimated by the QLQC-30 questionnaire(baseline to 24 months)
- Presence/absence of complications (Clavien)(24 months)