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Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

Not Applicable
Completed
Conditions
Thyroidectomy
Registration Number
NCT00784407
Lead Sponsor
Hippocration General Hospital
Brief Summary

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Detailed Description

Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • total thyroidectomy
Exclusion Criteria
  • hemithyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Hemostasisintraoperatively & postoperatively
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burnpostoperatively
Operative timefrom skin incision to skin closure
Secondary Outcome Measures
NameTimeMethod
Length of hospital staypostoperatively

Trial Locations

Locations (1)

Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens

🇬🇷

Athens, Abelokipoi (Q. Sofias 114 av.), Greece

Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
🇬🇷Athens, Abelokipoi (Q. Sofias 114 av.), Greece
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