NCT00892164

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hippocration General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Thyroidectomy

Interventions

Type	Name	Description
DEVICE	harmonic scalpel device (FOCUS)	hemostatic device utilized intraoperatively
DEVICE	electrothermal bipolar vessel sealing system (LIGASURE PRECISE)	hemostatic device utilized intraoperatively

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-12-01
• Completion: 2009-04-01
• First posted: 2009-05-04
• Last updated: 2009-05-04

Locations

1 site across 1 country: Greece