ThyroidectomyNCT00892164
Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer
A study testing harmonic scalpel device (FOCUS) and electrothermal bipolar vessel sealing system (LIGASURE PRECISE) in people with Thyroidectomy, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- harmonic scalpel device (FOCUS) and electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2008to Apr 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- total thyroidectomy
Who cannot join
- hemithyroidectomy or subtotal thyroidectomy
- additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens
Athens, Abelokipoi (Vas. Sofias 114 Av.), 11527
About this study
Official title: Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study
The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer.
Read the detailed description
The harmonic scalpel and the electrothermal bipolar vessel sealing system (LIGASURE PRECISE) have been both shown to be safe and effective in thyroid surgery. The moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (FOCUS) that has very recently been implemented and has been made available in 2008. Comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. The objective of this study is to compare the results of total thyroidectomy using the FOCUS to that with the LIGASURE device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with FOCUS (Group A) and those with LIGASURE (Group B).
- Conditions
- Thyroidectomy
- Being tested
- harmonic scalpel device (FOCUS), electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
- Keywords
- thyroid surgery, total thyroidectomy, harmonic scalpel, electrothermal bipolar vessel sealer, hemostatic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harmonic scalpel device (FOCUS)Device
hemostatic device utilized intraoperatively
electrothermal bipolar vessel sealing system (LIGASURE PRECISE)Device
hemostatic device utilized intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| FOCUS (Group A) | Active comparator | Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device Receives: Device: harmonic scalpel device (FOCUS) |
| LIGASURE (Group Β) | Active comparator | Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device Receives: Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
Measured: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Measured: postoperatively (from the day of surgery until 3-6 months postoperatively)
Operative time
Measured: from skin incision to skin closure
Secondary outcomes (1)
Length of hospital stay
Measured: postoperatively (from the day of surgery until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Manouras, MD, PhD, Principal investigator, Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892164
- Sponsor's protocol ID
- 642
- Status last verified
- May 2009
- First submitted
- 30 Apr 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00892164
- Acronym / sponsor ID
- 642
- Conditions
- Thyroidectomy
- Keywords
- thyroid surgery, total thyroidectomy, harmonic scalpel, electrothermal bipolar vessel sealer, hemostatic device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 May 2009 (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.
The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer.
Detailed description
The harmonic scalpel and the electrothermal bipolar vessel sealing system (LIGASURE PRECISE) have been both shown to be safe and effective in thyroid surgery. The moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (FOCUS) that has very recently been implemented and has been made available in 2008. Comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. The objective of this study is to compare the results of total thyroidectomy using the FOCUS to that with the LIGASURE device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with FOCUS (Group A) and those with LIGASURE (Group B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOCUS (Group A) | Active comparator | Device: harmonic scalpel device (FOCUS)Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device |
| LIGASURE (Group Β) | Active comparator | Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- total thyroidectomy
Key exclusion criteria (2 listed)
- hemithyroidectomy or subtotal thyroidectomy
- additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
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 |
|---|---|---|
| harmonic scalpel device (FOCUS)hemostatic device utilized intraoperatively | Device | FOCUS (Group A) |
| electrothermal bipolar vessel sealing system (LIGASURE PRECISE)hemostatic device utilized intraoperatively | Device | LIGASURE (Group Β) |
Primary outcome
Hemostasis
Time frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Time frame: postoperatively (from the day of surgery until 3-6 months postoperatively)
Operative time
Time frame: from skin incision to skin closure
1 secondary outcome
Length of hospital stay
Time frame: postoperatively (from the day of surgery until discharge)
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 4 May 2009.
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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.
Andreas Manouras, MD, PhD principal investigator
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing harmonic scalpel device (FOCUS) and electrothermal bipolar vessel sealing system (LIGASURE PRECISE) in people with Thyroidectomy, run by Hippocration General Hospital at 1 site in Greece.
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 2 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 4 May 2009. 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 Greece. 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?
Hemostasis (time frame: intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2009.