Benign Thoroid Disease Requiring Total ThyroidectomyNCT01649154
Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
A study testing Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus in people with Benign Thoroid Disease Requiring Total Thyroidectomy, run by Ospedale Regina Apostolorum at 1 site in Italy.
Trial summary
The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Thoroid Disease Requiring Total Thyroidectomy
- What is being tested?
- Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2011to May 2012
- 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
- Child, Adult, Older adult
Who may be able to join
- thyroid benign disease
Who cannot join
- malignant disease
- thyroid malign disease requiring lymphadenectomy
- coagulatory disease
Trial locations and contacts
1 site in 1 country.
About this study
The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.
Read the detailed description
A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.
- Being tested
- Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic FocusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ligasure Small-JAW | Active comparator | Not described Receives: Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
| Harmonic Focus | Active comparator | Not described Receives: Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
| Clamp-and-Tie technique | Active comparator | Not described Receives: Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
Secondary outcomes (1)
Cost assessment of new generation devices in thyroid surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Thoroid Disease Requiring Total 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regina Apostolorum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Cosenza, Ospedale Regina Apostolorum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649154
- Sponsor's protocol ID
- 8580/DS/CE
- Status last verified
- Jun 2012
- First submitted
- 24 Jun 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT01649154
- Acronym / sponsor ID
- 8580/DS/CE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ospedale Regina ApostolorumUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jul 2012 (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 Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.
Detailed description
A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ligasure Small-JAW | Active comparator | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
| Harmonic Focus | Active comparator | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
| Clamp-and-Tie technique | Active comparator | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- thyroid benign disease
Key exclusion criteria (3 listed)
- malignant disease
- thyroid malign disease requiring lymphadenectomy
- coagulatory disease
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 |
|---|---|---|
| Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus | Procedure or surgery | Clamp-and-Tie technique, Harmonic Focus, Ligasure Small-JAW |
Primary outcome
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
1 secondary outcome
Cost assessment of new generation devices in thyroid surgery
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 25 Jul 2012.
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 Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus in people with Benign Thoroid Disease Requiring Total Thyroidectomy, run by Ospedale Regina Apostolorum at 1 site in Italy.
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 3 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 25 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 Italy. 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?
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.. 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 25 Jul 2012.