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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOCUS (Group A) | Active Comparator | Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device |
|
| LIGASURE (Group Β) | Active Comparator | Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| harmonic scalpel device (FOCUS) | Device | hemostatic device utilized intraoperatively |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | postoperatively (from the day of surgery until discharge) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Manouras, MD, PhD | Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens | Athens | Abelokipoi (Vas. Sofias 114 Av.) | 11527 | Greece |
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| electrothermal bipolar vessel sealing system (LIGASURE PRECISE) |
| Device |
hemostatic device utilized intraoperatively |
|