Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466070
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-20
First Post:
2024-05-29
Brief Title:
Robotic Surgery in Pulmonary Metastasectomy
Sponsor:
Scientific Institute San Raffaele
Organization:
Scientific Institute San Raffaele
Study Overview
Official Title:
The Role of Robotic Surgery in Pulmonary Metastasectomy a Retrospective Multicenter Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROME
Brief Summary:
The study is observational multicenter retrospective and will involve multiple research centers The aim is to outline the indications for surgical management with robot-assisted pulmonary metastasectomy through a confrontation of robot-assisted thoracoscopic surgery RATS with video-assisted thoracoscopic surgery VATS and thoracotomy The study will focus on pulmonary metastasectomies from any primary solid tumor with the exception of lung cancer There are no risks for the patients as this is a retrospective data collection
Detailed Description:
The investigators will identify selection criteria according to ASA score American Society of Anaesthesiologists physical status classification system and co-morbidities respiratory function control and staging of the primary pathology number and position of metastases The investigators will assess the robotic approach performance in the different anatomical resections lobectomies bilobectomies segmentectomiespneumectomies considering potential intra- and post-operative complications over than rates of positive margins
It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery RATS and video-assisted thoracoscopic surgery VATS or with a traditional open approach More precisely it will compare RATS vs VATS as well as RATS vs open
It was decided to exclude simple wedge resections since in light of the minimal resection of parenchyma and the costs sustained for the equipment they are preferably carried out by VATS
Criteria for the inclusion of patients
1 The patient can be candidate in terms of ASA score cardiac kidney liver and respiratory function
2 The primary pathology is under control or controllable
3 Absence of extrapulmonary metastases that are not controlled or controllable
Exclusion criteria
Age then 18 years at the moment of surgery
Patients who cannot undergo surgery as they do not meet the conditions outlined above
It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery RATS and video-assisted thoracoscopic surgery VATS or with a traditional open approach More precisely it will compare RATS vs VATS as well as RATS vs open
It was decided to exclude simple wedge resections since in light of the minimal resection of parenchyma and the costs sustained for the equipment they are preferably carried out by VATS
Criteria for the inclusion of patients
1 The patient can be candidate in terms of ASA score cardiac kidney liver and respiratory function
2 The primary pathology is under control or controllable
3 Absence of extrapulmonary metastases that are not controlled or controllable
Exclusion criteria
Age then 18 years at the moment of surgery
Patients who cannot undergo surgery as they do not meet the conditions outlined above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None