To hear about similar clinical trials, please enter your email below
Trial Title:
Cost-effectiveness Evaluation of Robotic Surgery in the Removal of Lung Lesions in the ATS of Milan
NCT ID:
NCT05674227
Condition:
Lung Cancer
Conditions: Keywords:
Robotic surgery
Cost-effectiveness evaluation
Real-world data
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic surgery
Description:
Surgical treatment of operable lung cancers using robotic systems
Arm group label:
Robotic surgery
Intervention type:
Procedure
Intervention name:
Video-assisted thoracoscopy
Description:
Surgical treatment of operable lung cancers using a video-assisted thoracoscopy approach
(VAT)
Arm group label:
VAT surgery
Intervention type:
Procedure
Intervention name:
Open surgery
Description:
Surgical treatment of operable lung cancers using open surgery
Arm group label:
Open surgery
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Agenzia di Tutela della Salute della Città Metropolitana di Milano
Agency class:
Other
Collaborator:
Agency:
Istituto Europeo di Oncologia
Agency class:
Other
Collaborator:
Agency:
Humanitas Hospital, Italy
Agency class:
Other
Collaborator:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Collaborator:
Agency:
Ospedale San Raffaele
Agency class:
Other
Collaborator:
Agency:
ASST Grande Ospedale Metropolitano Niguarda
Agency class:
Other
Collaborator:
Agency:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Agency class:
Other
Collaborator:
Agency:
ASST Ovest Milanese, Ospedale Nuovo di Legnano
Agency class:
Other
Collaborator:
Agency:
IRCCS Multimedica
Agency class:
Other
Source:
Agenzia di Tutela della Salute della Città Metropolitana di Milano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674227
