Pulmonary Neoplasm
Conditions
Keywords
lobectomy, robot-assisted thoracoscopic surgery, lung cancer
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.
Interventions
PROCEDUREVATS lobectomy
a minimal invasive surgical types for NSCLC: VATS lobectomy
PROCEDURERATS lobectomy
a minimal invasive surgical types for NSCLC: RATS lobectomy
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. surgical indication for lobectomy; 2. minimal invasive surgery; 3. ASA (American Society of Anesthesiologists) stage: I-III; 4. sign the informed consent. -
Exclusion criteria
1. benign tumor or nodule; 2. present of other malignancy; 3. preoperative chemotherapy, radiotherapy, targeted therapy. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survival (OS) | 1 year after surgery | OS at 1 year after surgery |
| 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 |
| 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 |
| blood loss | postoperative in-hospital stay up to 30 days | blood loss 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 |
| length of stay (LOS) | postoperative in-hospital stay up to 30 days | length of stay in hospitalization |
| postoperative complications | postoperative in-hospital stay up to 30 days | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula |
| quality of life (QOL) at 3 month | at 3 month after surgery | QOL, WHOQOL-BREF |
| conversion rate | postoperative in-hospital stay up to 30 days | the rate of conversion to open surgery in the operation |
| 3-year disease-free survival (DFS) | 3 year after surgery | DFS at 3 year after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| total hospitalization expenditures | postoperative in-hospital stay up to 30 days | cost in hospital |
Countries
China
Outcome results
None listed