Mesenteric Vessel Sealing by Three Instruments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121614
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

Brief Summary:

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.


  • 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.

Condition or disease Intervention/treatment Phase
Surgery Device: LOTUS Device: Ethicon Harmonic Scalpel Device: LigaSure bipolar vessel sealing device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: LOTUS
LOTUS ultrasonic instrument
Device: LOTUS
Device used to seal blood vessel

Experimental: Ethicon Harmonic Scalpel
Ultrasonic instrument
Device: Ethicon Harmonic Scalpel
Experimental: LigaSure
Bipolar feedback vessel sealing device
Device: LigaSure bipolar vessel sealing device

Primary Outcome Measures :
  1. Bursting pressure of sealed vessel [ Time Frame: 1 day ]
    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"

Secondary Outcome Measures :
  1. Success/failure to seal vessel [ Time Frame: 1 day ]
    Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete

  2. Depth of collateral damage [ Time Frame: After histological fixation is complete; within one week ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121614

United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
Sponsors and Collaborators
University Hospital Plymouth NHS Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital Plymouth NHS Trust Identifier: NCT01121614     History of Changes
Other Study ID Numbers: 06/Q2103/139
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by University Hospital Plymouth NHS Trust:
Harmonic scalpel
ultrasonic scalpel
vessel sealing
burst pressure
collateral damage

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs