Lung CancerNCT05674227
Cost-effectiveness Evaluation of Robotic Surgery in the Removal of Lung Lesions in the ATS of Milan
An observational study of Lung Cancer, run by Agenzia di Tutela della Salute della Città Metropolitana di Milano.
Trial summary
The goal of this observational study is to compare cost-effectiveness of robotic surgery with open surgery and video-assisted thoracoscopy surgery (VATS) in adult patients, resident in the ATS of Milan area, operated for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Robotic surgery, Video-assisted thoracoscopy and Open surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Sep 2023
- How long will I take part?
- 5 Years
- 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: The retrospective study will include all adult subjects (age equal or over 18 years of age at the time of surgery) residents in the ATS of Milan, who were hospitalized between 01/01/2016 and 31/12/2021 for pulmonary surgery and whose hospitalization is present in the hospital discharge summary form database of the ATS of Milan in one of the participating centers. For the evaluation of cost-effectiveness in malignant tumors, subjects with metastases at diagnosis will be excluded. As for the prospective part of the study, all subjects who will undergo lung surgery during the first six month of 2023 at the participating centers and will give their consent to participate in the study by signing the informed consent form at the pre-hospitalization or at hospitalization before surgery will be eligible to be enrolled
Who may be able to join
- Retrospective study
- Patients operated on for a lung tumor in the participating Centers from 01/01/2016 to 12/31/2021
- Residents in the ATS of Milan area
- Hospitalization is present in the hospital discharge summary form database of the ATS of Milan
- Prospective study
- Patients operated on for lung tumor in the participating Centers from 01/01/2023 to 06/30/2023, who give their consent to be enrolled in the study
- Residents in the ATS of Milan area
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cost-effectiveness Evaluation of Robotic Surgery, Compared to Thoracoscopic and Open Surgery, in the Removal of Lung Lesions Based on "Real-world" Efficacy and Cost Data From the ATS of Milan
The goal of this observational study is to compare cost-effectiveness of robotic surgery with open surgery and video-assisted thoracoscopy surgery (VATS) in adult patients, resident in the ATS of Milan area, operated for lung cancer.
The main question it aims to answer is:
- Is the robotic surgery cost-effective compared with thoracotomy and VATS in the surgical treatment of operable lung cancers in the adult population of the ATS of Milan?
Researchers will compare robotic surgery with open and VAT surgery of operable lung cancer to see if robotic surgery performs better in terms of cost per year of life gained or in terms of cost per quality of life earned.
Read the detailed description
Single multicenter retrospective observational study with Real World Evidence (RWE) approach, i.e. an evaluation that uses real-world data (RWD) derived from healthcare flows of the ATS of Milan and data provided by participating centers on the basis of medical records/ clinical databases, both as regards the analysis of efficacy and safety and as regards the economic evaluation of direct costs.
For the analysis of quality of life and the calculation of QALYs (quality-adjusted life years), validated questionnaires will be prospectively administered to the participating subjects. The Epidemiology Unit of the ATS of Milan is the study promoter and it will coordinate the collection of data and will carry out the statistical and economic analyses. Other participating centers will be the thoracic surgeries of the ATS hospitals, which carried out in 2019 (last pre-pandemic COVID-19 year) at least 50 lung operations.
As for the retrospective part of the study, both for the evaluation of clinical efficacy and of costs, the investigators will include all adult subjects (age equal or over 18 years of age at the time of surgery) residents in the ATS of Milan, who were hospitalized between 01/01/2016 and 31/12/2021 for pulmonary surgery (operation codes in any position of the hospital discharge summary form (SDO-Scheda di Dimissione Ospedaliera) and whose hospitalization is present in the SDO database of the ATS of Milan in one of the participating centers. For the evaluation of cost-effectiveness in malignant tumors, subjects with metastases at diagnosis will be excluded.
As for the prospective part of the study, all subjects who will undergo lung surgery during 2023 at the participating centers and will give their consent to participate in the study by signing the informed consent form at the pre-hospitalization or at hospitalization before surgery will be eligible to be enrolled. To evaluate the quality of life PROMs related, the investigators will use the generic questionnaire EuroQol-5 Dimension (EQ-5D-5L) and the specific European Organization for Researchand Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORCT QLQ-LC29), which are available and validated in Italian. The pre-intervention questionnaire will be completed on paper during hospitalization before the intervention or at pre-admission and the data will be entered into the web application of the ATS of Milan by dedicated staff. The subsequent questionnaires at day 7 and 30 can be self-completed by patients or electronically, using the dedicated web application of the ATS of Milan or in paper form, by filling in the documents issued on discharge for this purpose
The cost-effectiveness evaluation will be conducted according to the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) guidelines.
- Conditions
- Lung Cancer
- Being tested
- Robotic surgery, Video-assisted thoracoscopy, Open surgery
- Keywords
- Robotic surgery, Cost-effectiveness evaluation, Real-world data
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Surgical treatment of operable lung cancers using robotic systems
Video-assisted thoracoscopyProcedure or surgery
Surgical treatment of operable lung cancers using a video-assisted thoracoscopy approach (VAT)
Open surgeryProcedure or surgery
Surgical treatment of operable lung cancers using open surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Patients who have undergone pulmonary robotic surgery Receives: Procedure: Robotic surgery | |
| VAT surgery | Patients who have undergone pulmonary video-assisted thoracoscopy surgery (VATS) Receives: Procedure: Video-assisted thoracoscopy | |
| Open surgery | Patients who have undergone pulmonary open surgery Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of operable lung cancer
The ICER of robotic surgery compared with both VATS and open surgery is defined as the ratio between incremental costs associated with robotic surgery and the variation in effectiveness. Costs will be measured in Euros. Effectiveness will be considered both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as Euros/years; in the second, it will be measured as Euros/QALY. It will be evaluated in the treatment of operable lung cancer.
Measured: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Secondary outcomes (1)
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of benign lung lesions
The ICER of robotic surgery compared with both VATS and open surgery will be evaluated in the treatment of benign lesions in the same population considered for the primary outcome. ICER is defined as the ratio between incremental costs associated with robotic surgery and the variation in effectiveness. Costs will be measured in Euros. Effectiveness will be considered both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as Euros/years; in the second, it will be measured as Euros/QALY.
Measured: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Other
- Enrolment
- 5,400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Agenzia di Tutela della Salute della Città Metropolitana di Milano
- Sponsor type
- Other government
- Collaborators
- Istituto Europeo di Oncologia, Humanitas Hospital, Italy, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Ospedale San Raffaele, ASST Grande Ospedale Metropolitano Niguarda, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, ASST Ovest Milanese, Ospedale Nuovo di Legnano, IRCCS Multimedica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674227
- Sponsor's protocol ID
- 2699
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Evaluation of Robotic Surgery, Compared to Thoracoscopic and Open Surgery, in the Removal of Lung Lesions Based on "Real-world" Efficacy and Cost Data From the ATS of Milan
- ClinicalTrials.gov ID
- NCT05674227
- Acronym / sponsor ID
- 2699
- Conditions
- Lung Cancer
- Keywords
- Robotic surgery, Cost-effectiveness evaluation, Real-world data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- Agenzia di Tutela della Salute della Città Metropolitana di MilanoOther government
- Collaborators
- Istituto Europeo di Oncologia, Humanitas Hospital, Italy, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Ospedale San Raffaele, ASST Grande Ospedale Metropolitano Niguarda, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, ASST Ovest Milanese, Ospedale Nuovo di Legnano, IRCCS Multimedica
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 6 Jan 2023 (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.
The goal of this observational study is to compare cost-effectiveness of robotic surgery with open surgery and video-assisted thoracoscopy surgery (VATS) in adult patients, resident in the ATS of Milan area, operated for lung cancer.
The main question it aims to answer is:
- Is the robotic surgery cost-effective compared with thoracotomy and VATS in the surgical treatment of operable lung cancers in the adult population of the ATS of Milan?
Researchers will compare robotic surgery with open and VAT surgery of operable lung cancer to see if robotic surgery performs better in terms of cost per year of life gained or in terms of cost per quality of life earned.
Detailed description
Single multicenter retrospective observational study with Real World Evidence (RWE) approach, i.e. an evaluation that uses real-world data (RWD) derived from healthcare flows of the ATS of Milan and data provided by participating centers on the basis of medical records/ clinical databases, both as regards the analysis of efficacy and safety and as regards the economic evaluation of direct costs.
For the analysis of quality of life and the calculation of QALYs (quality-adjusted life years), validated questionnaires will be prospectively administered to the participating subjects. The Epidemiology Unit of the ATS of Milan is the study promoter and it will coordinate the collection of data and will carry out the statistical and economic analyses. Other participating centers will be the thoracic surgeries of the ATS hospitals, which carried out in 2019 (last pre-pandemic COVID-19 year) at least 50 lung operations.
As for the retrospective part of the study, both for the evaluation of clinical efficacy and of costs, the investigators will include all adult subjects (age equal or over 18 years of age at the time of surgery) residents in the ATS of Milan, who were hospitalized between 01/01/2016 and 31/12/2021 for pulmonary surgery (operation codes in any position of the hospital discharge summary form (SDO-Scheda di Dimissione Ospedaliera) and whose hospitalization is present in the SDO database of the ATS of Milan in one of the participating centers. For the evaluation of cost-effectiveness in malignant tumors, subjects with metastases at diagnosis will be excluded.
As for the prospective part of the study, all subjects who will undergo lung surgery during 2023 at the participating centers and will give their consent to participate in the study by signing the informed consent form at the pre-hospitalization or at hospitalization before surgery will be eligible to be enrolled. To evaluate the quality of life PROMs related, the investigators will use the generic questionnaire EuroQol-5 Dimension (EQ-5D-5L) and the specific European Organization for Researchand Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORCT QLQ-LC29), which are available and validated in Italian. The pre-intervention questionnaire will be completed on paper during hospitalization before the intervention or at pre-admission and the data will be entered into the web application of the ATS of Milan by dedicated staff. The subsequent questionnaires at day 7 and 30 can be self-completed by patients or electronically, using the dedicated web application of the ATS of Milan or in paper form, by filling in the documents issued on discharge for this purpose
The cost-effectiveness evaluation will be conducted according to the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | – | Procedure: Robotic surgeryPatients who have undergone pulmonary robotic surgery |
| VAT surgery | – | Procedure: Video-assisted thoracoscopyPatients who have undergone pulmonary video-assisted thoracoscopy surgery (VATS) |
| Open surgery | – | Procedure: Open surgeryPatients who have undergone pulmonary open surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The retrospective study will include all adult subjects (age equal or over 18 years of age at the time of surgery) residents in the ATS of Milan, who were hospitalized between 01/01/2016 and 31/12/2021 for pulmonary surgery and whose hospitalization is present in the hospital discharge summary form database of the ATS of Milan in one of the participating centers. For the evaluation of cost-effectiveness in malignant tumors, subjects with metastases at diagnosis will be excluded. As for the prospective part of the study, all subjects who will undergo lung surgery during the first six month of 2023 at the participating centers and will give their consent to participate in the study by signing the informed consent form at the pre-hospitalization or at hospitalization before surgery will be eligible to be enrolled
Key inclusion criteria (7 listed)
- Retrospective study
- Patients operated on for a lung tumor in the participating Centers from 01/01/2016 to 12/31/2021
- Residents in the ATS of Milan area
- Hospitalization is present in the hospital discharge summary form database of the ATS of Milan
- Prospective study
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 |
|---|---|---|
| Robotic surgerySurgical treatment of operable lung cancers using robotic systems | Procedure or surgery | Robotic surgery |
| Video-assisted thoracoscopySurgical treatment of operable lung cancers using a video-assisted thoracoscopy approach (VAT) | Procedure or surgery | VAT surgery |
| Open surgerySurgical treatment of operable lung cancers using open surgery | Procedure or surgery | Open surgery |
Primary outcome
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of operable lung cancer
Time frame: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
The ICER of robotic surgery compared with both VATS and open surgery is defined as the ratio between incremental costs associated with robotic surgery and the variation in effectiveness. Costs will be measured in Euros. Effectiveness will be considered both in terms of life years gained, measured in years, and in terms of quality of life gained, measured in QALY. In the first case, ICER will be measured as Euros/years; in the second, it will be measured as Euros/QALY. It will be evaluated in the treatment of operable lung cancer.
1 secondary outcome
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of benign lung lesions
Time frame: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Agenzia di Tutela della Salute della Città Metropolitana di Milano.
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 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio G Russo, MD (+39 02 8578 2111, agrusso@ats-milano.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of operable lung cancer (time frame: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.). 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 1 Feb 2023.