Clinical trial NCT02462356: Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer
Official title: A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: CVATS
UVATS
perioperative effect
ergonomic influence
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: short-term quality of life(EQ5D) between the two groups
timeFrame: Up to 6 month
Secondary outcomes:
measure: intra-operative and postoperative complications
timeFrame: form the day of surgery up to discharege (expected within 1 month)
measure: lung function
timeFrame: pre-operative, 3 weeks, 3 months after surgery
measure: Pain Scores after surgery
timeFrame: 1, 3 days and 1, 3 months after surgery
measure: The surgeon's ergonomic influence during operation(blinks/min)
timeFrame: The video is capture every 5 minutes and lasted for 1 minute
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital Zhejiang university school of medicine
state: Zhejiang
Study officials:
References:
citation: Yao J, Chang Z, Zhu L, Fan J. Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22719. doi: 10.1097/MD.0000000000022719.