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
1 other identifier
interventional
18
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable surgery
Started Apr 2008
Shorter than P25 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedJuly 9, 2012
July 1, 2012
2 months
May 7, 2010
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bursting pressure of sealed vessel
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"
1 day
Secondary Outcomes (2)
Success/failure to seal vessel
1 day
Depth of collateral damage
After histological fixation is complete; within one week
Study Arms (3)
LOTUS
EXPERIMENTALLOTUS ultrasonic instrument
Ethicon Harmonic Scalpel
EXPERIMENTALUltrasonic instrument
LigaSure
EXPERIMENTALBipolar feedback vessel sealing device
Interventions
Eligibility Criteria
You may qualify if:
- Patient undergoing laparoscopic or open colorectal resection
You may not qualify if:
- Pregnant or lactating women
- Patients under eighteen years of age
- History of coagulation abnormality
- Inability to understand the nature of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Related Publications (1)
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.
PMID: 21442611DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 12, 2010
Study Start
April 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
July 9, 2012
Record last verified: 2012-07