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Completed

NCT Number: NCT01121614

Mesenteric Vessel Sealing by Three Instruments

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derriford Hospital

Plymouth, Devon, PL6 8DH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOTUS

Device

Device used to seal blood vessel

Ethicon Harmonic Scalpel

Device

LigaSure bipolar vessel sealing device

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 12, 2010
Registry last updated
Jul 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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