An interventional study of VATS and RATS in Lung Cancer, sponsored by Istituto Clinico Humanitas. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Istituto Clinico Humanitas · Not applicable, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VATS lobectomy or segmentectomy
Procedure: VATS
Robotic lobectomy or segmentectomy
Procedure: RATS
Thorax thoracoscopic surgery (lobectomy)
Also known as: Minimally invasive video-assisted surgery
Thorax robotic surgery (lobectomy)
Also known as: Minimally invasive robot-assisted surgery
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)
Time frame: date of Surgery
Postoperative complications: surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days
Time frame: within 90 days
Duration of surgery
Time frame: date of Surgery
Number of resected lymph nodes and upstaging
Time frame: date of Surgery
Proportion of patients who undergo complete resection during the procedure
Time frame: date of Surgery
Postoperative hospital stay
Time frame: 2 weeks
Postoperative pain: daily evaluation with visual numeric scale before and after surgery until discharge
Time frame: 2 weeks, 6 months and 12 months
Quality of life by EORTC QOL-C30
Time frame: 2 weeks, 6 months and 12 months
Duration of analgesic use after discharge and time to return to normal daily activity
Time frame: within 90 days
Postoperative respiratory function: FEV 1, PEF and CV
Time frame: 6 month postoperatively
Rate of local and distant recurrence and disease free survival
Time frame: 24 months
Patient's immune response: analysis of PCR, serum interleukins, lymphocytes subpopulations
Time frame: before surgery, 2 hours after surgery and at 3rd and 14th postoperative day
Plan to share: Undecided
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas