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

April 13, 2010 updated by: The First Affiliated Hospital of Guangzhou Medical University

Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With Rigid Spreading Versus Soft Spreading (Using LAP Protector)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical College
        • Principal Investigator:
          • Jianxing He, MD, FACS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with non-small cell lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The rigid spreading
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the level of postoperative pain between the rigid and soft spreading groups
Time Frame: 1 day
The level of postoperative pain was measured by Visual Analogue Scale (VAS).
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare early postoperative analgesic requirements between the rigid and soft spreading groups
Time Frame: 1 week
Postoperative analgesic requirements (e.g. the amount of morphine titration).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Jianxing He, MD, FACS, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

April 13, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAHG20100320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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