Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

Thyroidectomy Clinical Trial

Official title:

Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784407
• Other study ID #: 18858
• Status: Completed
• Phase: N/A
• First received: November 3, 2008
• Last updated: November 3, 2008
• Start date: February 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• 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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Description:

Although the harmonic scalpel has been shown to be safe and effective in thyroid surgery, several surgeons consider the previously available instruments to be large and cumbersome, especially in terms of tissue fine grasping and dissection capabilities. To this context, an innovative technical improvement of the device for thyroid surgery has very recently been implemented and has been made available in 2008. Utilization of this new device, however, has not been evaluated in any study. The objective of this prospective randomized study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE) in respect to hemostasis, operative time and postoperative complications. All patients submitted to total thyroidectomy are randomized into two groups: those submitted to total thyroidectomy using the FOCUS device (group Α) and those with HARMONIC ACE (group Β).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• total thyroidectomy

Exclusion Criteria:

• hemithyroidectomy

• 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 utilized intraoperatively
harmonic scalpel device utilized intraoperatively (FOCUS in group A and HARMONIC ACE in group B patients)

Locations

Country	Name	City	State
Greece	Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocratio General Hospital of Athens, Athens Medical School, University of Athens	Athens	Abelokipoi (Q. 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 & postoperatively	Yes
Primary	Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn		postoperatively	Yes
Primary	Operative time		from skin incision to skin closure	No
Secondary	Length of hospital stay		postoperatively	No