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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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

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Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOCUS (Group A)

Patients submitted to total thyroidectomy with the use of the FOCUS harmonic scalpel device

Group Type ACTIVE_COMPARATOR

harmonic scalpel device (FOCUS)

Intervention Type DEVICE

hemostatic device utilized intraoperatively

LIGASURE (Group Β)

Patients submitted to total thyroidectomy with the use of the electrothermal bipolar vessel sealing device

Group Type ACTIVE_COMPARATOR

electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

Intervention Type DEVICE

hemostatic device utilized intraoperatively

Interventions

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harmonic scalpel device (FOCUS)

hemostatic device utilized intraoperatively

Intervention Type DEVICE

electrothermal bipolar vessel sealing system (LIGASURE PRECISE)

hemostatic device utilized intraoperatively

Intervention Type DEVICE

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens

Principal Investigators

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Andreas Manouras, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrine Surgery, 1st Department of Propaedeutic Surgery, Hippocration General Hospital of Athens, Athens Medical School, University of Athens, Athens, Greece