SurgeryNCT01121614
Mesenteric Vessel Sealing by Three Instruments
A study testing LOTUS, Ethicon Harmonic Scalpel and LigaSure bipolar vessel sealing device in people with Surgery, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- LOTUS, Ethicon Harmonic Scalpel and LigaSure bipolar vessel sealing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing laparoscopic or open colorectal resection
Who cannot join
- Pregnant or lactating women
- Patients under eighteen years of age
- History of coagulation abnormality
- Inability to understand the nature of the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Surgery
- Being tested
- LOTUS, Ethicon Harmonic Scalpel, LigaSure bipolar vessel sealing device
- Keywords
- Harmonic scalpel, ultrasonic scalpel, LOTUS, LigaSure, vessel sealing, burst pressure, collateral damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOTUSDevice
Device used to seal blood vessel
Ethicon Harmonic ScalpelDevice
LigaSure bipolar vessel sealing deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| LOTUS | Experimental | LOTUS ultrasonic instrument Receives: Device: LOTUS |
| Ethicon Harmonic Scalpel | Experimental | Ultrasonic instrument Receives: Device: Ethicon Harmonic Scalpel |
| LigaSure | Experimental | Bipolar feedback vessel sealing device Receives: Device: LigaSure bipolar vessel sealing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 1 day
Secondary outcomes (2)
Success/failure to seal vessel
Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete
Measured: 1 day
Depth of collateral damage
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
Measured: After histological fixation is complete; within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121614
- Sponsor's protocol ID
- 06/Q2103/139
- Status last verified
- Jul 2012
- First submitted
- 7 May 2010
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21442611
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01121614
- Acronym / sponsor ID
- 06/Q2103/139
- Conditions
- Surgery
- Keywords
- Harmonic scalpel, ultrasonic scalpel, LOTUS, LigaSure, vessel sealing, burst pressure, collateral damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LOTUS | Experimental | Device: LOTUSLOTUS ultrasonic instrument |
| Ethicon Harmonic Scalpel | Experimental | Device: Ethicon Harmonic ScalpelUltrasonic instrument |
| LigaSure | Experimental | Device: LigaSure bipolar vessel sealing deviceBipolar feedback vessel sealing device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing laparoscopic or open colorectal resection
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients under eighteen years of age
- History of coagulation abnormality
- Inability to understand the nature of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOTUSDevice used to seal blood vessel | Device | LOTUS |
| Ethicon Harmonic Scalpel | Device | Ethicon Harmonic Scalpel |
| LigaSure bipolar vessel sealing device | Device | LigaSure |
Primary outcome
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"
2 secondary outcomes
Success/failure to seal vessel
Time frame: 1 day
Depth of collateral damage
Time frame: After histological fixation is complete; within one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Derived from this study: PubMed 21442611Noble 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOTUS, Ethicon Harmonic Scalpel and LigaSure bipolar vessel sealing device in people with Surgery, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bursting pressure of sealed vessel (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012; AzTrials last refreshed its copy on 1 Nov 2026.