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

Prospective, Randomized, Multicentric Study On Videothoracoscopic (Vats) Vs Robotic Approach For Lobectomy Or Anatomical Segmentectomy In Patients Affected By Early Lung Cancer (ROMAN)

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.

Intraoperative complications: conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other)

Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days

Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge

Inclusion Criteria: Age older than 18 years old Known or suspected lung cancers Patients in clinical stage T1-T2, N0-N1 candidate to surgery lobectomy or anatomical segmentectomy ASA-1-2-3 Exclusion Criteria: Clinical stage >II Severe heart disease Alcohol abuse Renal impairment (creatinine >2.5) Presence of serious comorbidities

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