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Mesenteric Vessel Sealing by Three Instruments

NCT ID: NCT01121614

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

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.

Detailed Description

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Conditions

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Surgery

Keywords

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Harmonic scalpel ultrasonic scalpel LOTUS LigaSure vessel sealing burst pressure collateral damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LOTUS

LOTUS ultrasonic instrument

Group Type EXPERIMENTAL

LOTUS

Intervention Type DEVICE

Device used to seal blood vessel

Ethicon Harmonic Scalpel

Ultrasonic instrument

Group Type EXPERIMENTAL

Ethicon Harmonic Scalpel

Intervention Type DEVICE

LigaSure

Bipolar feedback vessel sealing device

Group Type EXPERIMENTAL

LigaSure bipolar vessel sealing device

Intervention Type DEVICE

Interventions

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LOTUS

Device used to seal blood vessel

Intervention Type DEVICE

Ethicon Harmonic Scalpel

Intervention Type DEVICE

LigaSure bipolar vessel sealing device

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Derriford Hospital

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21442611 (View on PubMed)

Other Identifiers

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06/Q2103/139

Identifier Type: -

Identifier Source: org_study_id