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

Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer: a Prospective Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892164

Enrollment

120

Registered

2009-05-04

Start date

2008-08-31

Completion date

2009-04-30

Last updated

2009-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

Keywords

thyroid surgery, total thyroidectomy, harmonic scalpel, electrothermal bipolar vessel sealer, hemostatic device

Brief summary

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.

Detailed 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).

Interventions

DEVICEharmonic scalpel device (FOCUS)

hemostatic device utilized intraoperatively

DEVICEelectrothermal bipolar vessel sealing system (LIGASURE PRECISE)

hemostatic device utilized intraoperatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
Length of hospital stay	postoperatively (from the day of surgery until discharge)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026