Lung Cancer Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 5400 |
Est. completion date | September 30, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Agenzia di Tutela della Salute della Città Metropolitana di Milano | ASST Grande Ospedale Metropolitano Niguarda, ASST Ovest Milanese, Ospedale Nuovo di Legnano, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Humanitas Hospital, Italy, IRCCS Multimedica, Istituto Europeo di Oncologia, Ospedale San Raffaele |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology. | |
Secondary | 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. | The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology. |
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