Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorScientific Institute San Raffaele
About this trial
The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.
Age > then 18 years at the moment of surgery
Disqualifiers
Age < then 18 years at the moment of surgery
diagnosis other than NSCLC
Trial population
Patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy (case) and video-assisted thoracoscopic (VATS) or open segmentectomy (control)
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
472 Participants
are grouped into 2 trial groupsGroup A: Case group : Robotic Approach
Group B: Control group: video-assisted thoracoscopic surgery (VATS) and open
Trial outcomes
Primary outcomes
1
The perioperative complications of robotic approach
The investigators will measure the perioperative complications of robotic lung resection in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame
from the surgery at 30-90 days after2
The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach
The investigators will measure the perioperative complications of video-assisted thoracoscopic surgery (VATS) appraoch in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame
30-90 days after surgery3
The perioperative complications of the open approach
The investigators will measure the perioperative complications of open approach in patients with a pre or post-operative diagnosis of non-small cell lung cancer (NSCLC). Complications will be categorized according to the Clavien-Dindo scale.
Time frame
30-90 days after surgerySecondary outcomes
1
Duration of surgery
Duration of the surgery based on the approach measured in minutes
Time frame
up to 1 month2
Quality of lymphadenectomy
Number of lymphonodes station resected
Time frame
up to 1 month3
Conversion rate
Number of surgery procedures converted
Time frame
up to 1 month4
Survival analysis
Presence or absence of local and distant relapse
Time frame
up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Scientific Institute San Raffaele
Lead sponsor
Istituto Clinico Humanitas
Collaborator
Istituto Europeo di Oncologia
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Source ClinicalTrials.gov