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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01104233
First received: April 13, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Lung Cancer
Device: LAP Protector

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • Compare the level of postoperative pain between the rigid and soft spreading groups [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The level of postoperative pain was measured by Visual Analogue Scale (VAS).


Secondary Outcome Measures:
  • Compare early postoperative analgesic requirements between the rigid and soft spreading groups [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Postoperative analgesic requirements (e.g. the amount of morphine titration).


Estimated Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The soft spreading
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).
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
Other Name: Lap Protector
The rigid spreading
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with non-small cell lung cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104233

Contacts
Contact: Xin Xu, MD +86-20-83337792 yichunrenjia@126.com
Contact: Wenlong Shao, MD +86-20-83337792 myfriends2003@126.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Weiqiang Yin, MD    +86-20-83337792    yinwq88@21cn.com   
Contact: Daoyuan Wang, MD    +86-20-83337792    ghealth2008@gmail.com   
Principal Investigator: Jianxing He, MD, FACS         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Jianxing He, MD, FACS The First Affiliated Hospital of Guangzhou Medical University
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College
ClinicalTrials.gov Identifier: NCT01104233     History of Changes
Other Study ID Numbers: FAHG20100320
Study First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Video-assisted Thoracoscopic Surgery
Soft spreading
LAP Protector

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014