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

May 7, 2010
July 5, 2012
April 2008
June 2008   (final data collection date for primary outcome measure)
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"
Same as current
Complete list of historical versions of study NCT01121614 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Mesenteric Vessel Sealing by Three Instruments
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Surgery
  • Device: LOTUS
    Device used to seal blood vessel
  • Device: Ethicon Harmonic Scalpel
  • Device: LigaSure bipolar vessel sealing device
  • Experimental: LOTUS
    LOTUS ultrasonic instrument
    Intervention: Device: LOTUS
  • Experimental: Ethicon Harmonic Scalpel
    Ultrasonic instrument
    Intervention: Device: Ethicon Harmonic Scalpel
  • Experimental: LigaSure
    Bipolar feedback vessel sealing device
    Intervention: Device: LigaSure bipolar vessel sealing device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01121614
06/Q2103/139
No
Plymouth Hospitals NHS Trust
Plymouth Hospitals NHS Trust
Not Provided
Not Provided
Plymouth Hospitals NHS Trust
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP