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Thyroid NeoplasmPhase 4NCT00385983

Total Thyroidectomy With Harmonic Scalpel®

A Phase 4 study testing Harmonic Scalpel in people with Thyroid Neoplasm and Goiter, run by Brazilian Society of Head and Neck Surgery at 9 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Neoplasm, Goiter, Thyroid Nodule
What is being tested?
Harmonic Scalpel
Type of treatment
Medical device
How many people
280 participants
Where
9 sitesBrazil
Study dates
Start not givento not given
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (>18 y/o)
  • Benign or malignant thyroid disease
  • Proposal of total thyroidectomy
  • Normal thyroid function

Who cannot join

  • Giant goiter
  • Hyperthyroidism
  • Non differentiated thyroid carcinoma
  • Locally invasive tumors
  • Neck dissection as a part of procedure
  • Previous surgery, radiotherapy or I131 therapy on neck
Show all 9Show fewer
  • Video-assisted or endoscopic thyroidectomy
  • Severe comorbidities
  • Coagulation disorders

Trial locations and contacts

9 sites in 1 country.

Luiz P Kowalski, PhD contact

55-11-33410325

lp_kowalski@uol.com.br

Andre L Carvalho contact

alopescarvalho@uol.com.br

9 sites in 1 country

Brazil9 sites

  • Hospital Erasto Gaertner

    Curitiba, Paraná

    Paola Pedruzzi, MSc

  • Hospital Araujo Jorge

    Goiânia, Goiás

    Maria P Curado, PhD

  • Hospital do Cancer de Natal

    Natal, Rio Grande do Norte

    Fernando Pinto, MD

  • Instituto Nacional de Cancer INCA

    Rio de Janeiro, Rio de Janeiro

    Roberto Araujo Lima, PhD

  • Hospital do Cancer AC Camargo

    São Paulo, São Paulo

    Luiz P Kowalski, PhD

  • Hospital Heliopolis

    São Paulo, São Paulo

    Carlos Lehn, PhD

  • Hospital Sao Paulo-UNIFESP

    São Paulo, São Paulo

    Fernando Walder

  • Instituto Arnaldo Vieira de Carvalho

    São Paulo, São Paulo

    Jose de Gois Filho, MD

  • Santa Casa de Misericordia

    São Paulo, São Paulo

    Antonio J Gonçalves, PhD

Other trials in Brazil

About this study

Official title: Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial

Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures.

Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications

Read the detailed description

This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.

Being tested
Harmonic Scalpel
Keywords
thyroidectomy, thyroid neoplasm, postoperative complications, cost effectiveness
Medical subject headings
Thyroid Neoplasms, Goiter, Thyroid Nodule, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Harmonic ScalpelDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative complications

Secondary outcomes (5)

  1. Operative time

  2. Drainage volume

  3. Postoperative pain

  4. Length of stay

  5. Direct Costs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
280 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385983
Sponsor's protocol ID
CP005
Status last verified
Oct 2006
First submitted
10 Oct 2006
Last updated
11 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Harmonic Scalpel in people with Thyroid Neoplasm and Goiter, run by Brazilian Society of Head and Neck Surgery at 9 sites in Brazil.

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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luiz P Kowalski, PhD (55-11-33410325, lp_kowalski@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative complications. 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 NCT00385983.

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 11 Oct 2006.

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