Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 15, 2010
March 1, 2010
7 months
April 13, 2010
April 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Compare early postoperative analgesic requirements between the rigid and soft spreading groups
1 week
Study Arms (2)
The soft spreading
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).
The rigid spreading
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.
Interventions
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
Eligibility Criteria
Patients with non-small cell lung cancer
You may qualify if:
- Non-small cell lung cancer stage IB - IIIA
- ECOG status 0-1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianxing He, MD, FACS
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
April 15, 2010
Record last verified: 2010-03