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

Hippocration General Hospital

Status: Completed

Conditions: Thyroidectomy

Treatments: Device: harmonic scalpel device (FOCUS); Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

Study type: Interventional

Funder types: Other

Identifiers

NCT00892164

642

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 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 (FOCUS)

LIGASURE (Group Β)

Active Comparator group

Description:

Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device

Treatment:

Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)