Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Procedure: Conventional VATSProcedure: Uniportal VATS
- Registration Number
- NCT02462356
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.
- Detailed Description
Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.
However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
- Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
- Patients with an American Society of Anesthesiology score of 0-1.
- Patients with N2 or N3 positive or distant metastasis.
- Patients who had undergone Neoadjuvant chemotherapy.
- Patients with tumor invasion to the peripheral structures.
- Patients with previous history of thoracic operations.
- Patients with serious thoracic adhesion.
- Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.
- Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;
- Patients with cardiac, hepatic, or renal dysfunction;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional VATS Conventional VATS Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer Uniportal VATS Uniportal VATS Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer
- Primary Outcome Measures
Name Time Method short-term quality of life(EQ5D) between the two groups Up to 6 month To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.
- Secondary Outcome Measures
Name Time Method lung function pre-operative, 3 weeks, 3 months after surgery lung function will be measured at pre-operative, 3 weeks, 3 months after surgery
Pain Scores after surgery 1, 3 days and 1, 3 months after surgery Pain Scores will be measured by Brief pain inventory
intra-operative and postoperative complications form the day of surgery up to discharege (expected within 1 month) Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured.
The surgeon's ergonomic influence during operation(blinks/min) The video is capture every 5 minutes and lasted for 1 minute Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)
Trial Locations
- Locations (1)
The second affiliated hospital Zhejiang university school of medicine
🇨🇳Hangzhou, Zhejiang, China