Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor

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.

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Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial nephrectomy with robot-assisted and open surgery

Procedure

Robot-assisted partial nephrectomy (RAPN) is considered as a feasible minimally invasive alternative to open partial nephrectomy (OPN) for the surgical treatment of renal tumors. The main advantages of this technique include a three-dimensional magnified view of the surgical field, enhanced dexterity, and greater precision in both dissection and reconstruction.

Primary outcomes

Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted

Time frame: 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

Secondary outcomes

Difference in hospital stay duration between robot-assisted and open surgery

Time frame: one year

hospital stay represent a relevent indicator measuring effectiveness of intervention

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Health Economic Assessment of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in the Context of Renal Tumor

Acronym: écoREIN

Important dates

Study start: 2008
Primary completion: 2019
Study completion: 2021
First posted: Oct 22, 2021
Registry last updated: Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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