Surgery
Conditions
Keywords
Harmonic scalpel, ultrasonic scalpel, LOTUS, LigaSure, vessel sealing, burst pressure, collateral damage
Brief 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.
Interventions
DEVICELOTUS
Device used to seal blood vessel
DEVICEEthicon Harmonic Scalpel
DEVICELigaSure bipolar vessel sealing device
Sponsors
University Hospital Plymouth NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient undergoing laparoscopic or open colorectal resection
Exclusion criteria
* Pregnant or lactating women * Patients under eighteen years of age * History of coagulation abnormality * Inability to understand the nature of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bursting pressure of sealed vessel | 1 day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success/failure to seal vessel | 1 day | Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete |
| Depth of collateral damage | After histological fixation is complete; within one week | 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 |
Countries
United Kingdom
Outcome results
None listed