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

Hippocration General Hospital

Status: Completed

Conditions: Thyroidectomy

Treatments: Device: harmonic scalpel device utilized intraoperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT00784407

18858

Details and patient eligibility

About

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).

Full 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).

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• total thyroidectomy

Exclusion criteria

• hemithyroidectomy
• additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

FOCUS (group A)

Active Comparator group

Description:

Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device

Treatment:

Device: harmonic scalpel device utilized intraoperatively

HARMONIC ACE (group B)

Active Comparator group

Description:

Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device

Treatment:

Device: harmonic scalpel device utilized intraoperatively