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Total Thyroidectomy With Harmonic Scalpel®

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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
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Postoperative complications

Secondary Outcome Measures :
  1. Operative time
  2. Drainage volume
  3. Postoperative pain
  4. Length of stay
  5. Direct Costs

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Luiz P Kowalski, PhD 55-11-33410325 lp_kowalski@uol.com.br
Contact: Andre L Carvalho alopescarvalho@uol.com.br

Locations
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         
Sponsors and Collaborators
Brazilian Society of Head and Neck Surgery
Johnson & Johnson
Investigators
Principal Investigator: Luiz P Kowalski, PhD Brazilian Society of Head and Neck Surgery
More Information

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