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Total Thyroidectomy With Harmonic Scalpel®

NCT00385983 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2006-10-11

No results posted yet for this study

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

Conditions

  • Thyroid Neoplasm
  • Goiter
  • Thyroid Nodule

Interventions

DEVICE

Harmonic Scalpel

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Brazilian Society of Head and Neck Surgery

    lead OTHER

Principal Investigators

  • Luiz P Kowalski, PhD · Brazilian Society of Head and Neck Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385983 on ClinicalTrials.gov