Total Thyroidectomy With Harmonic Scalpel®
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00385983 |
Recruitment Status
: Unknown
Verified October 2006 by Brazilian Society of Head and Neck Surgery.
Recruitment status was: Not yet recruiting
First Posted
: October 11, 2006
Last Update Posted
: October 11, 2006
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Neoplasm Goiter Thyroid Nodule | Device: Harmonic Scalpel | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial |
- Postoperative complications
- Operative time
- Drainage volume
- Postoperative pain
- Length of stay
- Direct Costs

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (>18 y/o)
- Benign or malignant thyroid disease
- Proposal of total thyroidectomy
- Normal thyroid function
Exclusion Criteria:
- 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
- Video-assisted or endoscopic thyroidectomy
- Severe comorbidities
- Coagulation disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385983
Contact: Luiz P Kowalski, PhD | 55-11-33410325 | lp_kowalski@uol.com.br | |
Contact: Andre L Carvalho | alopescarvalho@uol.com.br |
Brazil | |
Hospital Araujo Jorge | Not yet recruiting |
Goiania, GO, Brazil | |
Principal Investigator: Maria P Curado, PhD | |
Hospital Erasto Gaertner | Not yet recruiting |
Curitiba, PR, Brazil | |
Principal Investigator: Paola Pedruzzi, MSc | |
Instituto Nacional de Cancer INCA | Not yet recruiting |
Rio de Janeiro, RJ, Brazil | |
Principal Investigator: Roberto Araujo Lima, PhD | |
Hospital do Cancer de Natal | Not yet recruiting |
Natal, RN, Brazil | |
Principal Investigator: Fernando Pinto, MD | |
Hospital do Cancer AC Camargo | Not yet recruiting |
Sao Paulo, SP, Brazil | |
Principal Investigator: Luiz P Kowalski, PhD | |
Hospital Heliopolis | Not yet recruiting |
Sao Paulo, SP, Brazil | |
Principal Investigator: Carlos Lehn, PhD | |
Hospital Sao Paulo-UNIFESP | Not yet recruiting |
Sao Paulo, SP, Brazil | |
Principal Investigator: Fernando Walder | |
Instituto Arnaldo Vieira de Carvalho | Not yet recruiting |
Sao Paulo, SP, Brazil | |
Principal Investigator: Jose de Gois Filho, MD | |
Santa Casa de Misericordia | Not yet recruiting |
Sao Paulo, SP, Brazil | |
Principal Investigator: Antonio J Gonçalves, PhD |
Principal Investigator: | Luiz P Kowalski, PhD | Brazilian Society of Head and Neck Surgery |
ClinicalTrials.gov Identifier: | NCT00385983 History of Changes |
Other Study ID Numbers: |
CP005 |
First Posted: | October 11, 2006 Key Record Dates |
Last Update Posted: | October 11, 2006 |
Last Verified: | October 2006 |
Keywords provided by Brazilian Society of Head and Neck Surgery:
thyroidectomy thyroid neoplasm postoperative complications cost effectiveness |
Additional relevant MeSH terms:
Thyroid Diseases Thyroid Nodule Thyroid Neoplasms Endocrine System Diseases |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |