Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
a minimal invasive surgical types for NSCLC: VATS lobectomy
a minimal invasive surgical types for NSCLC: RATS lobectomy
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
3-year overall survival (OS)
OS at 3 year after surgery
Time frame: 3 year after surgery
Lymph node counts
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Time frame: postoperative in-hospital stay up to 30 days
3-year disease-free survival (DFS)
DFS at 3 year after surgery
Time frame: 3 year after surgery
1-year overall survival (OS)
OS at 1 year after surgery
Time frame: 1 year after surgery
1-year disease-free survival (DFS)
DFS at 1 year after surgery
Time frame: 1 year after surgery
R0 rate
R0 radical rate
Time frame: postoperative in-hospital stay up to 30 days
margin state
positive margin rate
Time frame: postoperative in-hospital stay up to 30 days
operative time
the time of operation
Time frame: postoperative in-hospital stay up to 30 days
blood loss
blood loss in the operation
Time frame: postoperative in-hospital stay up to 30 days
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conversion rate
the rate of conversion to open surgery in the operation
Time frame: postoperative in-hospital stay up to 30 days
operative accident event
the accident event happened in operative
Time frame: postoperative in-hospital stay up to 30 days
30-day mortality
30-day mortality after surgery
Time frame: postoperative in-hospital stay up to 30 days
length of stay (LOS)
length of stay in hospitalization
Time frame: postoperative in-hospital stay up to 30 days
postoperative complications
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time frame: postoperative in-hospital stay up to 30 days
quality of life (QOL) at 3 month
QOL, WHOQOL-BREF
Time frame: at 3 month after surgery