NCT00385983

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

October 10, 2006

Last Update Submit

October 10, 2006

Conditions

Thyroid NeoplasmGoiterThyroid Nodule

Keywords

thyroidectomythyroid neoplasmpostoperative complicationscost effectiveness

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

Secondary Outcomes (5)

  • Operative time

  • Drainage volume

  • Postoperative pain

  • Length of stay

  • Direct Costs

Interventions

Harmonic ScalpelDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 y/o)
  • Benign or malignant thyroid disease
  • Proposal of total thyroidectomy
  • Normal thyroid function

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Location

Instituto Nacional de Cancer INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital do Cancer de Natal

Natal, Rio Grande do Norte, Brazil

Location

Hospital do Cancer AC Camargo

São Paulo, São Paulo, Brazil

Location

Hospital Heliopolis

São Paulo, São Paulo, Brazil

Location

Hospital Sao Paulo-UNIFESP

São Paulo, São Paulo, Brazil

Location

Instituto Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

Location

Santa Casa de Misericordia

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Thyroid NeoplasmsGoiterThyroid NodulePostoperative Complications

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luiz P Kowalski, PhD

    Brazilian Society of Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz P Kowalski, PhD

CONTACT

55-11-33410325lp_kowalski@uol.com.br

Andre L Carvalho

CONTACT

alopescarvalho@uol.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 11, 2006

Last Updated

October 11, 2006

Record last verified: 2006-10

Locations

BR(9)