Total Thyroidectomy With Harmonic Scalpel®

NCT ID: NCT00385983

Last Updated: 2006-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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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.

Conditions

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Thyroid Neoplasm Goiter Thyroid Nodule

Keywords

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thyroidectomy thyroid neoplasm postoperative complications cost effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Harmonic Scalpel

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Brazilian Society of Head and Neck Surgery

OTHER

Sponsor Role lead

Principal Investigators

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Luiz P Kowalski, PhD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Society of Head and Neck Surgery

Locations

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Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Site Status

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Site Status

Instituto Nacional de Cancer INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital do Cancer de Natal

Natal, Rio Grande do Norte, Brazil

Site Status

Hospital do Cancer AC Camargo

São Paulo, São Paulo, Brazil

Site Status

Hospital Heliopolis

São Paulo, São Paulo, Brazil

Site Status

Hospital Sao Paulo-UNIFESP

São Paulo, São Paulo, Brazil

Site Status

Instituto Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

Site Status

Santa Casa de Misericordia

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Luiz P Kowalski, PhD

Role: CONTACT

Phone: 55-11-33410325

Email: [email protected]

Andre L Carvalho

Role: CONTACT

Email: [email protected]

Other Identifiers

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CP005

Identifier Type: -

Identifier Source: org_study_id