ClinicalTrials.gg
RecruitingNCT06496386ELDERLYUpdated Nov 27, 2024

Robotic Assisted Major Lung Resection in Elderly Patients

An observational study in Lung Cancer, sponsored by Scientific Institute San Raffaele. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Scientific Institute San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
386
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Browse trials for

Keywords

  • robot-assisted thoracoscopic surgery
  • lung resection
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 386 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Scientific Institute San Raffaele is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 that are not controlled or controllable
  • All procedures included use of DaVinci robot system

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years at the moment of surgery
  • Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
386 participants (estimated)
Patient registry
No

Groups and cohorts

  • very elderly patients

    patients older than 80 years

  • elderly patients

    patients younger than 80 years

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. spirometry tests

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

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

  3. Postoperative hospital stay

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

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

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Sep 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2024
First posted
Jul 11, 2024
StartActual
Sep 30, 2024
Primary completionEst.
Sep 30, 2025
CompletionEst.
Oct 31, 2026
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06496386
Lead sponsor
Scientific Institute San Raffaele
Responsible party
Pierluigi Novellis (Medical doctor, Scientific Institute San Raffaele) — Principal investigator
First posted
Jul 11, 2024
Start date
Sep 30, 2024
Primary completion
Sep 30, 2025 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Nov 27, 2024

Study contacts

Pierluigi Novellis, MD
Contact
novellis.pierluigi@hsr.it
0226437202 ext. +39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion