Mesenteric Vessel Sealing by Three Instruments
Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic energy to cut through and coagulate tissue. An Ethicon version (trademarked "Harmonic Scalpel" and "Ultracision") is used in a variety of surgical procedures. Its surgical performance has been directly compared with that of electrically powered diathermy instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon, which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel. There are also bipolar feedback diathermy instruments which use electrical energy to seal blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure bipolar device reliably seal and divide blood vessels? The investigators will also be examining the degree of collateral tissue damage caused by each instrument.
- LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing mesenteric blood vessels.
- LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral damage when sealing and dividing blood vessels.
Device: Ethicon Harmonic Scalpel
Device: LigaSure bipolar vessel sealing device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||A Pilot Study to Compare Collateral Damage and Vessel Sealing Ability of LOTUS Ultrasonic Shears, Ethicon Harmonic Scalpel™ and LigaSure™ on Human Mesenteric Blood Vessels|
- Bursting pressure of sealed vessel [ Time Frame: 1 day ] [ Designated as safety issue: No ]Designated instrument is used to seal and divide a blood vessel which has been dissected from large bowel mesentery. The pressure at which the seal leaks is measured using a pressure transducer, this is known as the "bursting pressure"
- Success/failure to seal vessel [ Time Frame: 1 day ] [ Designated as safety issue: No ]Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete
- Depth of collateral damage [ Time Frame: After histological fixation is complete; within one week ] [ Designated as safety issue: No ]Energy-based surgical instruments cause a certain amount of thermal damage to the surrounding tissue, to compare the 3 instruments this depth of damage will be measured histologically
|Study Start Date:||April 2008|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
LOTUS ultrasonic instrument
Device used to seal blood vessel
Experimental: Ethicon Harmonic Scalpel
|Device: Ethicon Harmonic Scalpel|
Bipolar feedback vessel sealing device
|Device: LigaSure bipolar vessel sealing device|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121614
|Plymouth, Devon, United Kingdom, PL6 8DH|