Robotic Assisted Major Lung Resection in Elderly Patients

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06496386
• Lead Sponsor: Scientific Institute San Raffaele

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Study Start: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-09-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 386

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The perioperative complications	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	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	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.

Trial Locations

Locations (2)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy

Scientific Institute Ospedale San Raffaele; 🇮🇹 Milan, Italy