Non Small Cell Lung Cancer
Conditions
Keywords
CVATS, UVATS, perioperative effect, ergonomic influence
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.
Interventions
PROCEDUREUniportal VATS
Uniportal VATS lobectomy and lymph node dissection will be performed in this group
PROCEDUREConventional VATS
Conventional VATS lobectomy and lymph node dissection will be performed in this group
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
Countries
China
Outcome results
None listed