Robotic Assisted Major Lung Resection in Elderly Patients

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas, Rozzano, Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The perioperative complications

Time frame: from the surgery at 30-90 days after

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.
spirometry tests

Time frame: from hospitalizzation to the discharge date at maximum one week

the investigators will measure the pre-operative respiratory function (Forced expiratory volume (FEV) , forced vital capacity (FVC)), in the two groups .
Postoperative hospital stay

Time frame: from hospitalizzation to the discharge date at maximum one week

the investigators will measure the post-operative hospital stay in days in the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierluigi Novellis, MD

CONTACT

[email protected]

0226437202 ext. +39

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study

Acronym: ELDERLY

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Jul 11, 2024
Registry last updated: Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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