Mesenteric Vessel Sealing by Three Instruments

Study Overview
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Brief Summary
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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 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.

Official Title
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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

Conditions
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Surgery

Intervention / Treatment
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* Device: LOTUS
* Device: Ethicon Harmonic Scalpel
* Device: LigaSure bipolar vessel sealing device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOTUS<br>LOTUS ultrasonic instrument | Device: LOTUS<br>* Device used to seal blood vessel<br>|
| Experimental: Ethicon Harmonic Scalpel<br>Ultrasonic instrument | Device: Ethicon Harmonic Scalpel<br> <br> |
| Experimental: LigaSure<br>Bipolar feedback vessel sealing device | Device: LigaSure bipolar vessel sealing device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | After histological fixation is complete; within one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harmonic scalpel, ultrasonic scalpel, LOTUS, LigaSure, vessel sealing, burst pressure, collateral damage