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

This study has been completed.
Sponsor:
Information provided by:
Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT00784407
First received: November 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

November 3, 2008
November 3, 2008
February 2008
July 2008   (final data collection date for primary outcome measure)
  • Hemostasis [ Time Frame: intraoperatively & postoperatively ] [ Designated as safety issue: Yes ]
  • Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn [ Time Frame: postoperatively ] [ Designated as safety issue: Yes ]
  • Operative time [ Time Frame: from skin incision to skin closure ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Length of hospital stay [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

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).

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thyroidectomy
Device: harmonic scalpel device utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
  • Active Comparator: FOCUS (group A)
    Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
    Intervention: Device: harmonic scalpel device utilized intraoperatively
  • Active Comparator: HARMONIC ACE (group B)
    Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device
    Intervention: Device: harmonic scalpel device utilized intraoperatively
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
October 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • total thyroidectomy

Exclusion Criteria:

  • hemithyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00784407
18858
Yes
Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens
Hippocration General Hospital
Not Provided
Principal Investigator: Andreas Manouras, PhD Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece
Hippocration General Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP