Health Economic Assessment of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in the Context of Renal Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted
研究概览
简要总结
This study aim to analyze cost-effectiveness of robot-assisted surgery compared to open surgery for partial nephrectomy in the context of renal tumor. A total of 400 patients were recruited in two centers in France corresponding to Reims(n=200) and Nancy hospital center (n=200). Patients recruited in Reims are corresponding to open surgery strategy, while patients of Nancy center are corresponding to robot-assisted surgery.
Costs analyzed included cost of intervention, hospital stay and complications. Effectiveness measure is corresponding to the rate of patients without acute complication at one year.
详细描述
The main objective of this study is to analyze cost-effectiveness of robot-assisted surgery compared to open surgery in the context of partial nephrectomy for renal tumor. Many studies demonstrated a better post-operative outcome with robot-assisted surgery mainly in terms of lower rate of complications. Results in terms of oncologic outcomes were equivalent. However, no study in France has analyzed the economic incentives of implementing robot-assisted surgery in the context of partial nephrectomy. It is very likely that the higher cost of robot-assisted surgery could be offset by a lower cost of post-operatives complications. The secondary purpose of this study is to analyze difference between robot-assisted and open surgery procedures in terms of operative time, hospital stay duration and rate of minor complications.
The study is based on a retrospective cohort of 400 patients. Half of patients (N=200) were recruited in Nancy hospital center and are corresponding to the robot-assisted surgery procedure. The other half is corresponding to open surgery arm and where recruited in Reims hospital center.
Inclusion criteria refer concerns patients over 18 years that were operated for minor renal tumor in Nancy and Reims hospital center. Patients operated for total nephrectomy were excluded from the analysis.
Data collected refers to the cost and effectiveness of the two compared procedures. Cost data are issued from hospital records and included the cost of hospital stay, surgical intervention and potential complications. Data related to effectiveness are obtained from patients medical records.
Cost-effectiveness analysis will be conducted to estimate the cost per one averted case of post-operative complication at one year. This consists on calculating the incremental cost-effectiveness ratio (ICER). Sensitivity analysis will be also conducted in order to estimate de confidence interval for the ICER.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing partial nephrectomy surgery for renal tumor
- •Patients that gave informed consent for participating to the study
排除标准
- •Patients undergoing partial nephrectomy surgery for other indication
- •Patients that refused participation to the study
- •Patients with horseshoe kidney
- •Patients undergoing total nephrectomy for renal tumor
结局指标
主要结局
Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted
时间窗: one year
post-operative complication represents a relevant indicator in the context of renal nephrectomy. We aim to estimate the cost associated with one complication averted
次要结局
- Difference in hospital stay duration between robot-assisted and open surgery(one year)
研究者
Jacques HUBERT
Professeur
Central Hospital, Nancy, France