Renal TumorécoREINNCT05089006
Cost-effectivness of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in Context of Renal Tumor
An observational study of Renal Tumor, run by Central Hospital, Nancy, France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor
- What is being tested?
- Partial nephrectomy with robot-assisted and open surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old that undergone partial nephrectomy in Nancy and Reims center for small renal tumor.
Who may be able to join
- Patients undergoing partial nephrectomy surgery for renal tumor
- Patients that gave informed consent for participating to the study
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Tumor
- Being tested
- Partial nephrectomy with robot-assisted and open surgery
- Keywords
- kidney cancer, robot-assisted surgery, cost-effectiveness
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial nephrectomy with robot-assisted and open surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted surgery group | Patients undergoing robot-assisted surgery for small renal tumor Receives: Procedure: Partial nephrectomy with robot-assisted and open surgery | |
| open surgery group | Patients undergoing open surgery for small renal tumor Receives: Procedure: Partial nephrectomy with robot-assisted and open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted
post-operative complication represents a relevant indicator in the context of renal nephrectomy. We aim to estimate the cost associated with one complication averted
Measured: one year
Secondary outcomes (1)
Difference in hospital stay duration between robot-assisted and open surgery
hospital stay represent a relevent indicator measuring effectiveness of intervention
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jan 2008
- Primary completion1 Jan 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TumorStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacques HUBERT, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089006
- Sponsor's protocol ID
- écoREIN
- Acronym
- écoREIN
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no personal data will be shared
Publications
Baghli A, Achit H, Audige V, Larre S, Branchu B, Balkau B, Eschwege P, Hubert J, Mazeaud C. Cost-effectiveness of robotic-assisted surgery vs open surgery in the context of partial nephrectomy for small kidney tumors. J Robot Surg. 2023 Aug;17(4):1571-1578. doi: 10.1007/s11701-023-01552-8. Epub 2023 Mar 15.
PubMed 36918464
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic Assessment of Robot-assisted Surgery Compared to Open Surgery for Partial Nephrectomy in the Context of Renal Tumor
- ClinicalTrials.gov ID
- NCT05089006
- Acronym / sponsor ID
- écoREIN / écoREIN
- Conditions
- Renal Tumor
- Keywords
- kidney cancer, robot-assisted surgery, cost-effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted surgery group | – | Procedure: Partial nephrectomy with robot-assisted and open surgeryPatients undergoing robot-assisted surgery for small renal tumor |
| open surgery group | – | Procedure: Partial nephrectomy with robot-assisted and open surgeryPatients undergoing open surgery for small renal tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old that undergone partial nephrectomy in Nancy and Reims center for small renal tumor.
Key inclusion criteria (2 listed)
- Patients undergoing partial nephrectomy surgery for renal tumor
- Patients that gave informed consent for participating to the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial nephrectomy with robot-assisted and open surgeryRobot-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. | Procedure or surgery | open surgery group, robot-assisted surgery group |
Primary outcome
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
1 secondary outcome
Difference in hospital stay duration between robot-assisted and open surgery
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Derived from this study: PubMed 36918464Baghli A, Achit H, Audige V, Larre S, Branchu B, Balkau B, Eschwege P, Hubert J, Mazeaud C. Cost-effectiveness of robotic-assisted surgery vs open surgery in the context of partial nephrectomy for small kidney tumors. J Robot Surg. 2023 Aug;17(4):1571-1578. doi: 10.1007/s11701-023-01552-8. Epub 2023 Mar 15.
- Individual participant dataSharing planned: No. no personal data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Tumor, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-effectiveness ratio estimating cost per one acute post-operative complication averted (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.