Clinical trial NCT05674227: Cost-effectiveness Evaluation of Robotic Surgery in the Removal of Lung Lesions in the ATS of Milan
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Robotic surgery
Cost-effectiveness evaluation
Real-world data
Lead sponsor: Agenzia di Tutela della Salute della Città Metropolitana di Milano
Sponsor class: OTHER_GOV
Collaborators: name: Istituto Europeo di Oncologia
name: Humanitas Hospital, Italy
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Ospedale San Raffaele
name: ASST Grande Ospedale Metropolitano Niguarda
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: ASST Ovest Milanese, Ospedale Nuovo di Legnano
name: IRCCS Multimedica
First posted: 2023-01-06
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of operable lung cancer
timeFrame: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Secondary outcomes:
measure: Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of benign lung lesions
timeFrame: The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Other outcomes:
Locations:
Study officials:
References: