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Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease

NCT00666315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2008-05-22

No results posted yet for this study

Summary

New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

Conditions

  • Benign Thyroid Disease

Sponsors & Collaborators

  • Ethicon Endo-Surgery (Europe) GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Belgium
  • Italy

Study Locations

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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 NCT00666315 on ClinicalTrials.gov