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Total Thyroidectomy With Harmonic Scalpel®

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Brazilian Society of Head and Neck Surgery.
Recruitment status was:  Not yet recruiting
Johnson & Johnson
Information provided by:
Brazilian Society of Head and Neck Surgery Identifier:
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted

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
Thyroid Nodule
Device: Harmonic Scalpel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00385983

Hospital Araujo Jorge
Goiania, GO, Brazil
Hospital Erasto Gaertner
Curitiba, PR, Brazil
Instituto Nacional de Cancer INCA
Rio de Janeiro, RJ, Brazil
Hospital do Cancer de Natal
Natal, RN, Brazil
Hospital do Cancer AC Camargo
Sao Paulo, SP, Brazil
Hospital Heliopolis
Sao Paulo, SP, Brazil
Hospital Sao Paulo-UNIFESP
Sao Paulo, SP, Brazil
Instituto Arnaldo Vieira de Carvalho
Sao Paulo, SP, Brazil
Santa Casa de Misericordia
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Brazilian Society of Head and Neck Surgery
Johnson & Johnson
Principal Investigator: Luiz P Kowalski, PhD Brazilian Society of Head and Neck Surgery
  More Information Identifier: NCT00385983     History of Changes
Other Study ID Numbers: CP005 
Study First Received: October 10, 2006
Last Updated: October 10, 2006

Keywords provided by Brazilian Society of Head and Neck Surgery:
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
Head and Neck Neoplasms processed this record on February 20, 2017