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

• Conditions: Lung Cancer
• Interventions: Device: LAP Protector

• Registration Number: NCT01104233
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Last Update Submitted: 2010-04-13
• Study First Posted: 2010-04-15
• Last Update Posted: 2010-04-15
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The soft spreading	LAP Protector	Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).

Primary Outcome Measures

Name	Time	Method
Compare the level of postoperative pain between the rigid and soft spreading groups	1 day	The level of postoperative pain was measured by Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Compare early postoperative analgesic requirements between the rigid and soft spreading groups	1 week	Postoperative analgesic requirements (e.g. the amount of morphine titration).

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China