Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: FOCUS (group A) 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)
|
| Active Comparator: HARMONIC ACE (group B) 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)
|
Outcome Measures
Primary Outcome Measures
- 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
- Length of hospital stay [postoperatively]
Eligibility Criteria
Criteria
Inclusion Criteria:
- total thyroidectomy
Exclusion Criteria:
-
hemithyroidectomy
-
additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 |
Sponsors and Collaborators
- Hippocration General Hospital
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18858