Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector

Study Overview
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Brief Summary
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The purpose of this study is to see if different types of spreading (rigid or soft) of Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.

Detailed Description
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The Lap-Protector (Hakko Co., Japan) is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings. If the two rings are pulled apart, the device assumes a cylindrical shape. The outer diameter of each flexible ring is 12 cm, and this device can be used for minilaparotomy wounds between 5 and 9cm long.

Official Title
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Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: LAP Protector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-small cell lung cancer stage IB - IIIA ECOG status 0-1 Exclusion Criteria: Prior chemotherapy and/or radiation therapy for lung cancer Peripheral neuropathy > grade 1 Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Medical condition that will not permit treatment or follow up according to the protocol Pregnant or nursing women HIV-positive patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The soft spreading<br>Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector). | Device: LAP Protector<br>* The LAP Protector is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings<br>|
| The rigid spreading<br>Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the level of postoperative pain between the rigid and soft spreading groups | The level of postoperative pain was measured by Visual Analogue Scale (VAS). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare early postoperative analgesic requirements between the rigid and soft spreading groups | Postoperative analgesic requirements (e.g. the amount of morphine titration). | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-assisted Thoracoscopic Surgery, Soft spreading, LAP Protector