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
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 13, 2010 | ||||||||
| Last Updated Date | April 13, 2010 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector | ||||||||
| Official Title ICMJE | Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector) | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with non-small cell lung cancer |
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| Condition ICMJE | Lung Cancer | ||||||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01104233 | ||||||||
| Other Study ID Numbers ICMJE | FAHG20100320 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Medical College | ||||||||
| Study Sponsor ICMJE | The First Affiliated Hospital of Guangzhou Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | The First Affiliated Hospital of Guangzhou Medical University | ||||||||
| Verification Date | March 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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