Robot-assisted vs VATS Lobectomy for NSCLC
- Conditions
- Pulmonary Neoplasm
- Interventions
- Procedure: RATS lobectomyProcedure: VATS lobectomy
- Registration Number
- NCT03134534
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- surgical indication for lobectomy;
- minimal invasive surgery;
- ASA (American Society of Anesthesiologists) stage: I-III;
- sign the informed consent. -
- benign tumor or nodule;
- present of other malignancy;
- preoperative chemotherapy, radiotherapy, targeted therapy. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RATS group RATS lobectomy Surgical procedure: RATS lobectomy VATS group VATS lobectomy Surgical procedure: VATS lobectomy
- Primary Outcome Measures
Name Time Method Lymph node counts postoperative in-hospital stay up to 30 days overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
3-year overall survival (OS) 3 year after surgery OS at 3 year after surgery
- Secondary Outcome Measures
Name Time Method 1-year overall survival (OS) 1 year after surgery OS at 1 year after surgery
margin state postoperative in-hospital stay up to 30 days positive margin rate
operative time postoperative in-hospital stay up to 30 days the time of operation
3-year disease-free survival (DFS) 3 year after surgery DFS at 3 year after surgery
length of stay (LOS) postoperative in-hospital stay up to 30 days length of stay in hospitalization
1-year disease-free survival (DFS) 1 year after surgery DFS at 1 year after surgery
R0 rate postoperative in-hospital stay up to 30 days R0 radical rate
blood loss postoperative in-hospital stay up to 30 days blood loss in the operation
conversion rate postoperative in-hospital stay up to 30 days the rate of conversion to open surgery in the operation
operative accident event postoperative in-hospital stay up to 30 days the accident event happened in operative
30-day mortality postoperative in-hospital stay up to 30 days 30-day mortality after surgery
quality of life (QOL) at 3 month at 3 month after surgery QOL, WHOQOL-BREF
postoperative complications postoperative in-hospital stay up to 30 days mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
🇨🇳Shanghai, Shanghai, China