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Total Thyroidectomy With Harmonic Scalpel®

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Brazilian Society of Head and Neck Surgery.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Brazilian Society of Head and Neck Surgery
ClinicalTrials.gov Identifier:
NCT00385983
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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 Intervention Phase
Thyroid Neoplasm
Goiter
Thyroid Nodule
 Device: Harmonic Scalpel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brazilian Society of Head and Neck Surgery:

Primary Outcome Measures:
  • Postoperative complications

Secondary Outcome Measures:
  • Operative time
  • Drainage volume
  • Postoperative pain
  • Length of stay
  • Direct Costs

Estimated Enrollment: 280
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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            
Santa Casa de Misericordia Not yet recruiting
Sao Paulo, SP, Brazil
Principal Investigator: Antonio J Gonçalves, PhD            
Instituto Arnaldo Vieira de Carvalho Not yet recruiting
Sao Paulo, SP, Brazil
Principal Investigator: Jose de Gois Filho, MD            
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

No publications provided

ClinicalTrials.gov Identifier: NCT00385983     History of Changes
Other Study ID Numbers: CP005
Study First Received: October 10, 2006
Last Updated: October 10, 2006
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Brazilian Society of Head and Neck Surgery:
thyroidectomy
thyroid neoplasm
postoperative complications
cost effectiveness

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Goiter
Thyroid Diseases
Thyroid Nodule
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013