Mesenteric Vessel Sealing by Three Instruments

University Hospital Plymouth NHS Trust18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Surgery

Interventions

LOTUSDEVICE

Device used to seal blood vessel

Ethicon Harmonic ScalpelDEVICE

LigaSure bipolar vessel sealing deviceDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Derriford Hospital

Plymouth, Devon, United Kingdom

Outcomes

Primary Outcomes

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"

Time frame: 1 day

Secondary Outcomes

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

Time frame: 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

Time frame: After histological fixation is complete; within one week

Data from ClinicalTrials.gov

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