跳至主要内容
临床试验/NCT00591552
NCT00591552招募中不适用

Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.

Sentara Cardiovascular Research Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Amount of chest tube drainage

研究概览

简要总结

In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required and minimizing length of stay; the Harmonic Scalpel will be compared to a control group which uses electrocautery. This study will assess these two different methods to determine if there is a notable decrease in the amount of drainage with one versus the other.

详细描述

Lymph node dissection is an integral part of the surgical management of lung cancer. Knowledge of lymph node status plays a key role in therapeutic decision making and prognosis. Associated with this dissection comes the propensity for lymphatic leakage, increased chest tube drainage, prolonged retention of chest tubes in the postoperative period and increased patient length of stay. Our center performs complete mediastinal node dissection of all relevant regional lymph nodes which generally include paratracheal, pretracheal, subcarinal, hilar and paraesophageal nodes. The current standard of practice for the dissection of the lymph nodes includes the use of the Harmonic Scalpel or electrocautery. Known risk of electrocautery include localized nerve damage, cardiac arrhythmias and damage to the tissue sample/specimen that is used for pathology. The Harmonic Scalpel technology has recently become available for use. Current experience with the Harmonic Scalpel suggests that there is less localized nerve damage, less incidence of arrhythmias, less damage to the tissue sample and less lymph leakage. There is no published data to support this hypothesis, thus the purpose of this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing resection for stage 1, 2 or 3A lung cancer.
  • Patients between the ages of 20-75.

排除标准

  • History of Congestive Heart Failure.
  • History of renal failure, ie., creatinine greater than 2.
  • Patients with bulky or matted lymph nodes in stage 3A.
  • Current pregnancy.
  • Current participation in another study involving an investigational device or drug.

结局指标

主要结局

Amount of chest tube drainage

时间窗: daily

次要结局

  • Pleural effusions monitored by chest x-ray.(Every other day and at four weeks)

研究者

发起方
Sentara Cardiovascular Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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