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Sponsored by: |
Hippocration General Hospital |
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Information provided by: | Hippocration General Hospital |
ClinicalTrials.gov Identifier: | NCT00784407 |
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 |
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Thyroidectomy |
Device: harmonic scalpel device utilized intraoperatively |
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 |
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 |
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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)
|
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).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 History of Changes |
Health Authority: | Greece: Ethics Committee |
thyroid surgery total thyroidectomy harmonic scalpel total thyroidectomy |