Robotic Assisted Major Lung Resection in Elderly Patients
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorScientific Institute San Raffaele
About this trial
The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.
There are no risks for the patients, as this is a retrospective data collection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years at the moment of surgery
Suspected or confirmed diagnosis of lung cancer
The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
Absence of extrapulmonary metastases that are not controlled or controllable
Disqualifiers
Age < 18 years at the moment of surgery
Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Trial population
the study will focus on the population of subjects undergoing lung resection with the DaVinci surgical platform from May 2015 to December 2022. The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy or pneumonectomy using robotic system.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
386 Participants
are grouped into 2 trial groupsGroup A: very elderly patients
Group B: elderly patients
Trial outcomes
Primary outcomes
1
The perioperative complications
the investigators will measure the perioperative complications of robotic lung resection in patients with 80 or more than 80 years (very elderly patients) compared to those with less than 80 years. Complications will be categorized according to the Clavien-Dindo scale.
Time frame
from the surgery at 30-90 days after2
spirometry tests
the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups .
Time frame
from hospitalizzation to the discharge date at maximum one week3
Postoperative hospital stay
the investigators will measure the post-operative hospital stay in days in the two groups.
Time frame
from hospitalizzation to the discharge date at maximum one weekSponsors and contacts
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Source ClinicalTrials.gov