Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer (PORTaL)

Intuitive Surgical

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: Robotic-assisted lobectomy using da Vinci Surgical System; Procedure: Open lobectomy; Procedure: VATS (video assisted thoracic surgery)

Study type: Observational

Funder types: Industry

Identifiers

NCT03347825

ISI-dVLob-001

Details and patient eligibility

About

The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.

Full description

This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:

Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required

Enrollment: 7,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is 18 years or older
• Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy

Exclusion criteria

• Subject with stage IIIB lung cancer
• Subject who received lobectomy as an emergent procedure
• Subjects who received lobectomy for metastatic cancer

Trial design

7,000 participants in 3 patient groups

Robotic-assisted lobectomy

Description:

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent robotic-assisted lobectomy for lung cancer.

Treatment:

Procedure: Robotic-assisted lobectomy using da Vinci Surgical System

VATS (video assisted thoracic surgery) lobectomy

Description:

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent VATS lobectomy for lung cancer.

Treatment:

Procedure: VATS (video assisted thoracic surgery)

Open lobectomy

Description:

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent open lobectomy for lung cancer.

Treatment:

Procedure: Open lobectomy