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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: VATS
* Procedure: RATS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VATS GROUP<br>VATS lobectomy or segmentectomy | Procedure: VATS<br>* Thorax thoracoscopic surgery (lobectomy)<br>* Other names: Minimally invasive video-assisted surgery;|
| Active Comparator: RATS GROUP<br>Robotic lobectomy or segmentectomy | Procedure: RATS<br>* Thorax robotic surgery (lobectomy)<br>* Other names: Minimally invasive robot-assisted surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | date of Surgery | 
| Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days |  | within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | date of Surgery | 
| Number of resected lymph nodes and upstaging |  | date of Surgery | 
| Proportion of patients who undergo complete resection during the procedure |  | date of Surgery | 
| Postoperative hospital stay |  | 2 weeks | 
| Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge |  | 2 weeks, 6 months and 12 months | 
| Quality of life by EORTC QOL-C30 |  | 2 weeks, 6 months and 12 months | 
| Duration of analgesic use after discharge and time to return to normal daily activity |  | within 90 days | 
| Postoperative respiratory function: FEV 1, PEF and CV |  | 6 month postoperatively | 
| Rate of local and distant recurrence and disease free survival |  | 24 months | 
| Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations |  | before surgery, 2 hours after surgery and at 3rd and 14th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery