Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: Uniportal VATS
* Procedure: Conventional VATS


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional VATS<br>Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer | Procedure: Conventional VATS<br>* Conventional VATS lobectomy and lymph node dissection will be performed in this group<br>|
| Experimental: Uniportal VATS<br>Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer | Procedure: Uniportal VATS<br>* Uniportal VATS lobectomy and lymph node dissection will be performed in this group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short-term quality of life(EQ5D) between the two groups | To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups. | Up to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-operative and postoperative complications | Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured. | form the day of surgery up to discharege (expected within 1 month) | 
| lung function | lung function will be measured at pre-operative, 3 weeks, 3 months after surgery | pre-operative, 3 weeks, 3 months after surgery | 
| Pain Scores after surgery | Pain Scores will be measured by Brief pain inventory | 1, 3 days and 1, 3 months after surgery | 
| The surgeon's ergonomic influence during operation(blinks/min) | Spontaneous eye blink rate(NASA Task Load Index，NASA TLX) | The video is capture every 5 minutes and lasted for 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVATS, UVATS, perioperative effect, ergonomic influence