Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer

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 to that with the electrothermal bipolar vessel sealer.

Detailed Description
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The harmonic scalpel and the electrothermal bipolar vessel sealing system (LIGASURE PRECISE) have been both shown to be safe and effective in thyroid surgery. The moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (FOCUS) that has very recently been implemented and has been made available in 2008. Comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. The objective of this study is to compare the results of total thyroidectomy using the FOCUS to that with the LIGASURE device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with FOCUS (Group A) and those with LIGASURE (Group B).

Official Title
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Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study

Conditions
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Thyroidectomy

Intervention / Treatment
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* Device: harmonic scalpel device (FOCUS)
* Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total thyroidectomy Exclusion Criteria: hemithyroidectomy or subtotal thyroidectomy 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 (FOCUS)<br>* hemostatic device utilized intraoperatively<br>|
| Active Comparator: LIGASURE (Group Β)<br>Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device | Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)<br>* hemostatic device utilized intraoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis |  | intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively) | 
| Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn |  | postoperatively (from the day of surgery until 3-6 months postoperatively) | 
| Operative time |  | from skin incision to skin closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | postoperatively (from the day of surgery until discharge) | 

 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, electrothermal bipolar vessel sealer, hemostatic device