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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).
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).
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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 |
|
| HARMONIC ACE (group B) | Active Comparator | Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| harmonic scalpel device utilized intraoperatively | Device | harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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.) | 11527 | Greece |
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