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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Thyroidectomy

Intervention / Treatment
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* Device: harmonic scalpel device utilized intraoperatively


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total thyroidectomy Exclusion Criteria: hemithyroidectomy additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOCUS (group A)<br>Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device | Device: harmonic scalpel device utilized intraoperatively<br>* harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)<br>|
| Active Comparator: HARMONIC ACE (group B)<br>Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device | Device: harmonic scalpel device utilized intraoperatively<br>* harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis |  | intraoperatively & postoperatively | 
| Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn |  | postoperatively | 
| Operative time |  | from skin incision to skin closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid surgery, total thyroidectomy, harmonic scalpel