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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOTUS | Experimental | LOTUS ultrasonic instrument |
|
| Ethicon Harmonic Scalpel | Experimental | Ultrasonic instrument |
|
| LigaSure | Experimental | Bipolar feedback vessel sealing device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOTUS | Device | Device used to seal blood vessel |
| |
| Ethicon Harmonic Scalpel |
| Measure | Description | Time Frame |
|---|---|---|
| Bursting pressure of sealed vessel | 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" | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Success/failure to seal vessel | Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete | 1 day |
| Depth of collateral damage | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Derriford Hospital | Plymouth | Devon | PL6 8DH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21442611 | Derived | Noble EJ, Smart NJ, Challand C, Sleigh K, Oriolowo A, Hosie KB. Experimental comparison of mesenteric vessel sealing and thermal damage between one bipolar and two ultrasonic shears devices. Br J Surg. 2011 Jun;98(6):797-800. doi: 10.1002/bjs.7433. Epub 2011 Mar 25. |
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| Device |
|
| LigaSure bipolar vessel sealing device | Device |
|
| After histological fixation is complete; within one week |