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

Second Affiliated Hospital, School of Medicine, Zhejiang University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

Uniportal VATSPROCEDURE

Uniportal VATS lobectomy and lymph node dissection will be performed in this group

Conventional VATSPROCEDURE

Conventional VATS lobectomy and lymph node dissection will be performed in this group

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

The second affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 month

Secondary Outcomes

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.

Time frame: 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

Time frame: pre-operative, 3 weeks, 3 months after surgery

Pain Scores after surgery

Pain Scores will be measured by Brief pain inventory

Time frame: 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)

Time frame: The video is capture every 5 minutes and lasted for 1 minute

Data from ClinicalTrials.gov

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