Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Erectile function
研究概览
简要总结
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Localized prostate cancer
- •Gleason grade ≤ 3 + 4
- •PSA < 15 ng / mL
- •Stage ≤ T2b
- •Eligible to receive laparoscopic radical prostatectomy
- •Candidate bilateral or unilateral erectile preservation
排除标准
- •Patient at high risk of postoperative progression (PSA> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
- •Presenting erectile dysfunction (IIEF < 22)
- •Past history of urinary incontinence (> grade 1 WHO)
- •Body mass index > 30
结局指标
主要结局
Erectile function
时间窗: 12 months after surgery
Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.
次要结局
- Surgical margins(During surgery)
- Prostate Specific Antigen (PSA)(Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery)
- Continence(Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery)
- Tolerance(Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery)
- Quality of life(Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery)
- Incremental cost-effectiveness ratio(60 months afet surgery)