Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)
18 Years
80 Years
Both
Lung Cancer
Trial Information
Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)
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.
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
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
Compare the level of postoperative pain between the rigid and soft spreading groups
Outcome Description:
The level of postoperative pain was measured by Visual Analogue Scale (VAS).
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
Jianxing He, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
The First Affiliated Hospital of Guangzhou Medical University
Authority:
China: Food and Drug Administration
Study ID:
FAHG20100320
NCT ID:
NCT01104233
Start Date:
March 2010
Completion Date:
December 2010
Related Keywords:
- Lung Cancer
- Video-assisted Thoracoscopic Surgery
- Soft spreading
- LAP Protector
- Lung Neoplasms
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