Mesenteric Vessel Sealing by Three Instruments

University Hospital Plymouth NHS Trust

Status: Completed

Conditions: Surgery

Treatments: Device: Ethicon Harmonic Scalpel; Device: LigaSure bipolar vessel sealing device; Device: LOTUS

Study type: Interventional

Funder types: Other

Identifiers

NCT01121614

06/Q2103/139

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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18 participants in 3 patient groups

LOTUS

Experimental group

Description:

LOTUS ultrasonic instrument

Treatment:

Device: LOTUS

Ethicon Harmonic Scalpel

Experimental group

Description:

Ultrasonic instrument

Treatment:

Device: Ethicon Harmonic Scalpel

LigaSure

Experimental group

Description:

Bipolar feedback vessel sealing device

Treatment:

Device: LigaSure bipolar vessel sealing device