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临床试验/NCT01104233
NCT01104233Unknown不适用

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

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Compare the level of postoperative pain between the rigid and soft spreading groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-small cell lung cancer stage IB - IIIA
  • ECOG status 0-1

排除标准

  • 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

结局指标

主要结局

Compare the level of postoperative pain between the rigid and soft spreading groups

时间窗: 1 day

The level of postoperative pain was measured by Visual Analogue Scale (VAS).

次要结局

  • Compare early postoperative analgesic requirements between the rigid and soft spreading groups(1 week)

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other

研究点 (1)

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