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

NCT ID: NCT01104233

Last Updated: 2010-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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The soft spreading

Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).

LAP Protector

Intervention Type DEVICE

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

The rigid spreading

Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Guangzhou Medical College

Principal Investigators

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Jianxing He, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Xu, MD

Role: CONTACT

+86-20-83337792

Wenlong Shao, MD

Role: CONTACT

+86-20-83337792

Facility Contacts

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Weiqiang Yin, MD

Role: primary

+86-20-83337792

Daoyuan Wang, MD

Role: backup

+86-20-83337792

Other Identifiers

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FAHG20100320

Identifier Type: -

Identifier Source: org_study_id

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