Total Thyroidectomy With Harmonic Scalpel®

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

Arms and Interventions

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Outcome Measures

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00385983 History of Changes
Other Study ID Numbers:	CP005
First Posted:	October 11, 2006
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