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Mesenteric Vessel Sealing by Three Instruments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01121614
First received: May 7, 2010
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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.

Condition Intervention
Surgery
 Device: LOTUS
Device: Ethicon Harmonic Scalpel
Device: LigaSure bipolar vessel sealing device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Further study details as provided by Plymouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Bursting pressure of sealed vessel [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Success/failure to seal vessel [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete

  • Depth of collateral damage [ Time Frame: After histological fixation is complete; within one week ] [ Designated as safety issue: No ]
    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


Enrollment: 18
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121614

Locations
United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
Sponsors and Collaborators
Plymouth Hospitals NHS Trust
  More Information

No publications provided by Plymouth Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01121614     History of Changes
Other Study ID Numbers: 06/Q2103/139
Study First Received: May 7, 2010
Last Updated: July 5, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Plymouth Hospitals NHS Trust:
Harmonic scalpel
ultrasonic scalpel
LOTUS
LigaSure
 vessel sealing
burst pressure
collateral damage

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013