Robotic Assisted Major Lung Resection in Elderly Patients

NCT06496386 | Recruiting

• 1 other identifier: CET 234-2024
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

robot-assisted thoracoscopic surgery; lung resection

Outcome Measures

Primary Outcomes (3)

• The perioperative complications

  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.

  from the surgery at 30-90 days after

• spirometry tests

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

  from hospitalizzation to the discharge date at maximum one week

• Postoperative hospital stay

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

  from hospitalizzation to the discharge date at maximum one week

Study Arms (2)

very elderly patients

patients older than 80 years

elderly patients

patients younger than 80 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the study will focus on the population of subjects undergoing lung resection with the DaVinci surgical platform from May 2015 to December 2022. The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy or pneumonectomy using robotic system.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (2)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pierluigi Novellis, MD

CONTACT

0226437202; novellis.pierluigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 11, 2024
• Study Start: September 30, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

IT (2)