MedTrace Logo

Videothoracoscopic (VATS) vs. Robotic Approach for Lobectomy or Anatomical Segmentectomy

NCT02804893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-12-20

No results posted yet for this study

Summary

This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage (I-II) lung cancer. The expected recruitment is one year and two year follow up. Surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. Each participating centers should have the possibility to offer both techniques (Robotics and Vats). The primary end point is a combination of conversion and complication rate. The presence of at least one of the two events is considered a failure. Considering the rate of failure of 35% in the VATS arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.

Conditions

Interventions

PROCEDURE

VATS

Thorax thoracoscopic surgery (lobectomy)

PROCEDURE

RATS

Thorax robotic surgery (lobectomy)

Sponsors & Collaborators

  • Fondazione Umberto Veronesi

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2022-03-06
Completion
2023-03-06

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804893 on ClinicalTrials.gov