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Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
This study has been completed.
Sponsored by: Hippocration General Hospital
Information provided by: Hippocration General Hospital
ClinicalTrials.gov Identifier: NCT00784407
  Purpose

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).


Condition Intervention
Thyroidectomy
Device: harmonic scalpel device utilized intraoperatively

Drug Information available for: Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: postoperatively ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FOCUS (group A): Active Comparator
Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
Device: harmonic scalpel device utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)
HARMONIC ACE (group B): Active Comparator
Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device
Device: harmonic scalpel device utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total thyroidectomy

Exclusion Criteria:

  • hemithyroidectomy
  • additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784407

Locations
Greece, Abelokipoi (Q. Sofias 114 av.)
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, 11527
Sponsors and Collaborators
Hippocration General Hospital
Investigators
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
  More Information

Responsible Party: Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens ( Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens )
Study ID Numbers: 18858
Study First Received: November 3, 2008
Last Updated: November 3, 2008
ClinicalTrials.gov Identifier: NCT00784407  
Health Authority: Greece: Ethics Committee

Keywords provided by Hippocration General Hospital:
thyroid surgery
total thyroidectomy
harmonic scalpel
total thyroidectomy

ClinicalTrials.gov processed this record on January 16, 2009