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

G

Guangzhou Medical University

Status

Unknown

Conditions

Lung Cancer

Treatments

Device: LAP Protector

Study type

Observational

Funder types

Other

Identifiers

NCT01104233
FAHG20100320

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

The soft spreading
Description:
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with soft spreading (using LAP Protector).
Treatment:
Device: LAP Protector
The rigid spreading
Description:
Patients with lung cancer underwent Video-assisted Thoracoscopic Surgery (VATS) with rigid spreading.

Trial contacts and locations

1

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Central trial contact

Xin Xu, MD; Wenlong Shao, MD

Data sourced from clinicaltrials.gov

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