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

Hippocration General Hospital90 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thyroidectomy

Interventions

harmonic scalpel device utilized intraoperativelyDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * total thyroidectomy Exclusion Criteria: * hemithyroidectomy * additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)

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

Outcomes

Primary Outcomes

Hemostasis

Time frame: intraoperatively & postoperatively

Postoperative complications including laryngeal nerve palsy, hypocalcemia, hemorrhage, hematoma, wound infection and skin burn

Time frame: postoperatively

Operative time

Time frame: from skin incision to skin closure

Secondary Outcomes

Length of hospital stay

Time frame: postoperatively

Data from ClinicalTrials.gov

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