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

Thyroidectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892164
• Other study ID #: 642
• Status: Completed
• Phase: N/A
• First received: April 30, 2009
• Last updated: May 1, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: Hippocration General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Device:
• harmonic scalpel device (FOCUS)
hemostatic device utilized intraoperatively
• electrothermal bipolar vessel sealing system (LIGASURE PRECISE)
hemostatic device utilized intraoperatively

Locations

Country	Name	City	State
Greece	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.)

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis		intraoperatively (from skin incision to skin closure) & postoperatively (from skin closure until 1 week postoperatively)	Yes
Primary	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)	Yes
Primary	Operative time		from skin incision to skin closure	No
Secondary	Length of hospital stay		postoperatively (from the day of surgery until discharge)	No