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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Lung Cancer

Treatments: Procedure: RATS; Procedure: VATS

Study type: Interventional

Funder types: Other

Identifiers

NCT02804893

1566

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

VATS GROUP

Active Comparator group

Description:

VATS lobectomy or segmentectomy

Treatment:

Procedure: VATS

RATS GROUP

Active Comparator group

Description:

Robotic lobectomy or segmentectomy

Treatment:

Procedure: RATS