Robotic Assisted Major Lung Resection in Elderly Patients

NCT ID: NCT06496386

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.

Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).

the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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very elderly patients

patients older than 80 years

No interventions assigned to this group

elderly patients

patients younger than 80 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
* All procedures included use of DaVinci robot system

Exclusion Criteria

* Age \< 18 years at the moment of surgery
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pierluigi Novellis

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pierluigi Novellis, MD

Role: CONTACT

0226437202 ext. +39

Facility Contacts

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Giuseppe Marulli, MD

Role: primary

Pierluigi Novellis, MD

Role: primary

+39022643 ext. 7202

Other Identifiers

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CET 234-2024

Identifier Type: -

Identifier Source: org_study_id