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

NCT ID: NCT00784407

Last Updated: 2008-11-04

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

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 (FOCUS) to that with the previously available harmonic scalpel device (HARMONIC ACE).

Detailed Description

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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).

Conditions

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Thyroidectomy

Keywords

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thyroid surgery total thyroidectomy harmonic scalpel

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 utilized intraoperatively

Intervention Type DEVICE

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

HARMONIC ACE (group B)

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

Group Type ACTIVE_COMPARATOR

harmonic scalpel device utilized intraoperatively

Intervention Type DEVICE

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

Interventions

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harmonic scalpel device utilized intraoperatively

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* total thyroidectomy

Exclusion Criteria

* hemithyroidectomy
* additional surgical procedures together with the total thyroidectomy (i.e. parathyroidectomy or cervical lymph node dissection)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hippocration General Hospital

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Andreas Manouras, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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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

Site Status

Countries

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Greece

Other Identifiers

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18858

Identifier Type: -

Identifier Source: org_study_id