Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy. A Single Center Prospective Randomized Controlled Study.|
- Amount of chest tube drainage [ Time Frame: daily ] [ Designated as safety issue: No ]
- Pleural effusions monitored by chest x-ray. [ Time Frame: Every other day and at four weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Group A
Electrocautery used for dissection.
Active Comparator: Group B
Harmonic Scalpel used for dissection
Device: Harmonic ACE23P Scalpel
Lymph node dissection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591552
|Contact: Laura Pine, RN, BSNfirstname.lastname@example.org|
|Contact: Michelle Collier, RN, BSNemail@example.com|
|United States, Virginia|
|Sentara Norfolk General Hospital/Sentara Heart Hospital||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Laura Pine, RN, BSN 757-388-2732 firstname.lastname@example.org|
|Contact: Michelle Collier, RN, BSN 757-388-7511 email@example.com|
|Sub-Investigator: Kirk Fleischer, MD|
|Sub-Investigator: Michael McGrath, MD|
|Sub-Investigator: Jeffrey Rich, MD|
|Principal Investigator:||Joseph Newton, MD||Sentara Cardiovascular Research Institute|