Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Dec 2007
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 21, 2023
November 1, 2023
16.9 years
December 26, 2007
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of chest tube drainage
daily
Secondary Outcomes (1)
Pleural effusions monitored by chest x-ray.
Every other day and at four weeks
Study Arms (2)
Group A
ACTIVE COMPARATORElectrocautery used for dissection.
Group B
ACTIVE COMPARATORHarmonic Scalpel used for dissection
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing resection for stage 1, 2 or 3A lung cancer.
- Patients between the ages of 20-75.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sentara Cardiovascular Research Institutelead
- Ethicon Endo-Surgerycollaborator
Study Sites (1)
Sentara Norfolk General Hospital/Sentara Heart Hospital
Norfolk, Virginia, 23507, United States
Related Publications (3)
Holub Z, Jabor A, Kliment L, Lukac J, Voracek J. Laparoscopic lymph node dissection using ultrasonically activated shears: comparison with electrosurgery. J Laparoendosc Adv Surg Tech A. 2002 Jun;12(3):175-80. doi: 10.1089/10926420260188065.
PMID: 12184902BACKGROUNDLumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4.
PMID: 14964555BACKGROUNDKajiyama Y, Iwanuma Y, Tomita N, Amano T, Hattori K, Tsurumaru M. Sealing the thoracic duct with ultrasonic coagulating shears. Hepatogastroenterology. 2005 Jul-Aug;52(64):1053-6.
PMID: 16001628BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Newton, MD
Sentara Cardiovascular Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
December 1, 2007
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
November 21, 2023
Record last verified: 2023-11