Trials / Completed
CompletedNCT01121614
Mesenteric Vessel Sealing by Three Instruments
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University Hospital Plymouth NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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. Hypotheses * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LOTUS | Device used to seal blood vessel |
| DEVICE | Ethicon Harmonic Scalpel | |
| DEVICE | LigaSure bipolar vessel sealing device |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2010-05-12
- Last updated
- 2012-07-09
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01121614. Inclusion in this directory is not an endorsement.