ThyroidectomyNCT00784407
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
A study testing harmonic scalpel device utilized intraoperatively 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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- harmonic scalpel device utilized intraoperatively
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2008to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- total thyroidectomy
Who cannot join
- hemithyroidectomy
- 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, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
Athens, Abelokipoi (Q. Sofias 114 Av.), 11527
About this study
The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).
Read the detailed description
Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).
- Conditions
- Thyroidectomy
- Being tested
- harmonic scalpel device utilized intraoperatively
- Keywords
- thyroid surgery, total thyroidectomy, harmonic scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harmonic scalpel device utilized intraoperativelyDevice
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
| 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 utilized intraoperatively |
| HARMONIC ACE (group B) | Active comparator | Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device Receives: Device: harmonic scalpel device utilized intraoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
Measured: intraoperatively & postoperatively
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Measured: postoperatively
Operative time
Measured: from skin incision to skin closure
Secondary outcomes (1)
Length of hospital stay
Measured: postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionOct 2008
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Manouras, PhD, Principal investigator, Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784407
- Sponsor's protocol ID
- 18858
- Status last verified
- Oct 2008
- First submitted
- 3 Nov 2008
- Last updated
- 4 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00784407
- Acronym / sponsor ID
- 18858
- Conditions
- Thyroidectomy
- Keywords
- thyroid surgery, total thyroidectomy, harmonic scalpel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Nov 2008 (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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).
Detailed description
Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).
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 utilized intraoperativelyPatients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device |
| HARMONIC ACE (group B) | Active comparator | Device: harmonic scalpel device utilized intraoperativelyPatients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel 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
- 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 utilized intraoperativelyharmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients) | Device | FOCUS (group A), HARMONIC ACE (group B) |
Primary outcome
Hemostasis
Time frame: intraoperatively & postoperatively
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn
Time frame: postoperatively
Operative time
Time frame: from skin incision to skin closure
1 secondary outcome
Length of hospital stay
Time frame: postoperatively
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 Nov 2008.
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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, PhD principal investigator
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio 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 utilized intraoperatively 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 Nov 2008. 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 & 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 Nov 2008.