Cost-effectiveness Evaluation of Robotic Surgery in the Removal of Lung Lesions in the ATS of Milan
1 other identifier
observational
5,400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedFebruary 1, 2023
December 1, 2022
6 months
December 2, 2022
January 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incremental Cost-effectiveness ratio (ICER) of robotic surgery for the treatment of benign lung lesions
The time horizon of the evaluation will be limited to 5 years from the intervention and the purchase of the technology.
Study Arms (3)
Robotic surgery
Patients who have undergone pulmonary robotic surgery
VAT surgery
Patients who have undergone pulmonary video-assisted thoracoscopy surgery (VATS)
Open surgery
Patients who have undergone pulmonary open surgery
Interventions
Surgical treatment of operable lung cancers using robotic systems
Surgical treatment of operable lung cancers using a video-assisted thoracoscopy approach (VAT)
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agenzia di Tutela della Salute della Città Metropolitana di Milanolead
- Istituto Europeo di Oncologiacollaborator
- Humanitas Hospital, Italycollaborator
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milanocollaborator
- Ospedale San Raffaelecollaborator
- ASST Grande Ospedale Metropolitano Niguardacollaborator
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicocollaborator
- ASST Ovest Milanese, Ospedale Nuovo di Legnanocollaborator
- IRCCS Multimedicacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2022
First Posted
January 6, 2023
Study Start
March 1, 2023
Primary Completion
August 31, 2023
Study Completion
September 30, 2023
Last Updated
February 1, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share