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

October 21, 2021 updated by: Jacques HUBERT, Central Hospital, Nancy, France

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
robot-assisted surgery group
Patients undergoing robot-assisted surgery for small renal tumor
Procedure: Partial nephrectomy with robot-assisted and open surgery
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.
open surgery group
Patients undergoing open surgery for small renal tumor
Procedure: Partial nephrectomy with robot-assisted and open surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • écoREIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no personal data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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