Clinical trial NCT05089006: Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor
Official title: Health Economic Assessment of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in the Context of Renal Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Tumor
Keywords: kidney cancer
robot-assisted surgery
cost-effectiveness
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old that undergone partial nephrectomy in Nancy and Reims center for small renal tumor.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing partial nephrectomy surgery for renal tumor
* Patients that gave informed consent for participating to the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted
timeFrame: one year
Secondary outcomes:
measure: Difference in hospital stay duration between robot-assisted and open surgery
timeFrame: one year
Other outcomes:
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