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

Not Applicable

Completed

• Conditions: Thyroidectomy
• Interventions: Device: harmonic scalpel device (FOCUS); Device: electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

• Registration Number: NCT00892164
• Lead Sponsor: Hippocration General Hospital

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).

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study Completion: 2009-04
• Study First Submitted: 2009-04-30
• Status Verified: 2009-05
• Study First Submitted QC: 2009-05-01
• Last Update Submitted: 2009-05-01
• Study First Posted: 2009-05-04
• Last Update Posted: 2009-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCUS (Group A)	harmonic scalpel device (FOCUS)	Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
LIGASURE (Group Β)	electrothermal bipolar vessel sealing system (LIGASURE PRECISE)	Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of hospital stay	postoperatively (from the day of surgery until discharge)

Trial Locations

Locations (1)

Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens; 🇬🇷 Athens, Abelokipoi (Vas. Sofias 114 av.), Greece