SurgeryNCT03989739
A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
An observational study of Surgery, run by Fundación de investigación HM.
Trial summary
This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- Da Vinci
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2014to 31 Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was carried out at the General Surgery Department of Sanchinarro University Hospital of Madrid. Details of the procedure have been described in a previous report and standardized in both groups. RDP was performed using a da Vinci Robotic Surgical System model Si and Xi (Intuitive Surgical, Sunnyvale, CA, USA) (8). All consecutive cases were conducted by the same group of 6 surgeons all with considerable experience in both laparoscopic and robotic approaches. Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included and assigned either to RDP or LDP, depending on the availability of the robot. The indication for resection was given in the context of a multidisciplinary institutional committee.
Who may be able to join
- Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included.
- The indication for resection was given in the context of a multidisciplinary institutional committee
Who cannot join
- -
About this study
This is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.
- Conditions
- Surgery
- Being tested
- Da Vinci
- Keywords
- Cost-effectiveness, Pancreatectomy, Willingness to pay, Robotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da VinciDevice
| Study group | Role | What they receive |
|---|---|---|
| robotic distal pancreatectomy | Not described Receives: Device: Da Vinci | |
| laparoscopic distal pancreatectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-adjusted life years
Quality-adjusted life years
Measured: 2014-2018
ICER
Incremental Cost-effectiveness Ratio
Measured: 2014-2018
Costs
Direct costs
Measured: 2014-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Feb 2014
- Primary completion1 Feb 2014
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989739
- Sponsor's protocol ID
- Fundacionhm
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
- ClinicalTrials.gov ID
- NCT03989739
- Acronym / sponsor ID
- Fundacionhm
- Conditions
- Surgery
- Keywords
- Cost-effectiveness, Pancreatectomy, Willingness to pay, Robotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jun 2019 (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 is a clinical and cost-effectiveness analysis within a retrospective comparative study of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome parameters included surgical and post-operative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A sensitivity analysis was carried out in order to propagate the uncertainty of the estimations to the results of the model. The investigators use a multivariate and stochastic sensitivity analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to represent all pairs of solutions of the model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic distal pancreatectomy | – | Device: Da Vinci |
| laparoscopic distal pancreatectomy | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was carried out at the General Surgery Department of Sanchinarro University Hospital of Madrid. Details of the procedure have been described in a previous report and standardized in both groups. RDP was performed using a da Vinci Robotic Surgical System model Si and Xi (Intuitive Surgical, Sunnyvale, CA, USA) (8). All consecutive cases were conducted by the same group of 6 surgeons all with considerable experience in both laparoscopic and robotic approaches. Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included and assigned either to RDP or LDP, depending on the availability of the robot. The indication for resection was given in the context of a multidisciplinary institutional committee.
Key inclusion criteria (2 listed)
- Patients (aged over 18 years) with benign or malignant mass without evidence of major vessel involvement were included.
- The indication for resection was given in the context of a multidisciplinary institutional committee
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Da Vinci | Device | robotic distal pancreatectomy |
Primary outcome
Quality-adjusted life years
Time frame: 2014-2018
Quality-adjusted life years
ICER
Time frame: 2014-2018
Incremental Cost-effectiveness Ratio
Costs
Time frame: 2014-2018
Direct costs
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 18 Jun 2019.
- Individual participant dataSharing planned: No
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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 Surgery, run by Fundación de investigación HM.
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 1 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 18 Jun 2019. 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?
Quality-adjusted life years (time frame: 2014-2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2019.