Expired Study
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Norfolk, Virginia 23507


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients undergoing resection for stage 1, 2 or 3A lung cancer. - Patients between the ages of 20-75. Exclusion Criteria: - History of Congestive Heart Failure. - History of renal failure, ie., creatinine greater than 2.2. - Patients with bulky or matted lymph nodes in stage 3A. - Current pregnancy. - Current participation in another study involving an investigational device or drug.


NCT ID:

NCT00591552


Primary Contact:

Principal Investigator
Joseph Newton, MD
Sentara Cardiovascular Research Institute

Laura Pine, RN, BSN
Phone: 757-388-2732
Email: ljpine@sentara.com


Backup Contact:

Email: mlcollie@sentara.com
Michelle Collier, RN, BSN
Phone: 757-388-7511


Location Contact:

Norfolk, Virginia 23507
United States

Laura Pine, RN, BSN
Phone: 757-388-2732
Email: ljpine@sentara.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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