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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01104233
• Other study ID #: FAHG20100320
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 13, 2010
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Xin Xu, MD
• Phone: +86-20-83337792
• Email: yichunrenjia[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• LAP Protector
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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Compare early postoperative analgesic requirements between the rigid and soft spreading groups	Postoperative analgesic requirements (e.g. the amount of morphine titration).	1 week	No