Total Thyroidectomy With Harmonic Scalpel®

October 10, 2006 updated by: Brazilian Society of Head and Neck Surgery

Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • GO
      • Goiania, GO, Brazil
        • Hospital Araujo Jorge
        • Principal Investigator:
          • Maria P Curado, PhD
    • PR
      • Curitiba, PR, Brazil
        • Hospital Erasto Gaertner
        • Principal Investigator:
          • Paola Pedruzzi, MSc
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Instituto Nacional de Cancer INCA
        • Principal Investigator:
          • Roberto Araujo Lima, PhD
    • RN
      • Natal, RN, Brazil
        • Hospital do Cancer de Natal
        • Principal Investigator:
          • Fernando Pinto, MD
    • SP
      • Sao Paulo, SP, Brazil
        • Hospital do Cancer AC Camargo
        • Principal Investigator:
          • Luiz P Kowalski, PhD
      • Sao Paulo, SP, Brazil
        • Hospital Heliópolis
        • Principal Investigator:
          • Carlos Lehn, PhD
      • Sao Paulo, SP, Brazil
        • Hospital São Paulo-UNIFESP
        • Principal Investigator:
          • Fernando Walder
      • Sao Paulo, SP, Brazil
        • Instituto Arnaldo Vieira de Carvalho
        • Principal Investigator:
          • Jose de Gois Filho, MD
      • Sao Paulo, SP, Brazil
        • Santa Casa de Misericórdia
        • Principal Investigator:
          • Antonio J Gonçalves, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postoperative complications

Secondary Outcome Measures

Outcome Measure
Operative time
Length of stay
Postoperative pain
Drainage volume
Direct Costs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilian Society of Head and Neck Surgery

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Luiz P Kowalski, PhD, Brazilian Society of Head and Neck Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 10, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 10, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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