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
Recruitment status was Recruiting
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
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
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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
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 May 23, 2013