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

Not Applicable

Completed

• Conditions: Thyroidectomy
• Interventions: Device: harmonic scalpel device utilized intraoperatively

• Registration Number: NCT00784407
• 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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Detailed 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).

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-07
• Status Verified: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Last Update Submitted: 2008-11-03
• Study First Posted: 2008-11-04
• Last Update Posted: 2008-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCUS (group A)	harmonic scalpel device utilized intraoperatively	Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device
HARMONIC ACE (group B)	harmonic scalpel device utilized intraoperatively	Patients submitted to total thyroidectomy with the use of the HARMONIC ACE harmonic scalpel device

Primary Outcome Measures

Name	Time	Method
Hemostasis	intraoperatively & postoperatively
Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn	postoperatively
Operative time	from skin incision to skin closure

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	postoperatively

Trial Locations

Locations (1)

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.), Greece