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Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease

NCT ID: NCT00666315

Last Updated: 2008-05-22

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

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-04-30

Brief Summary

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New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

Detailed Description

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Thyroidectomy is one of the most frequently performed operations in endocrine surgery. Results are generally excellent, and morbidity and mortality are usually negligible. The operation requires proper identification of important structures such as the recurrent laryngeal nerve (RLN) and the parathyroid glands. Meticulous dissection and exhaustive hemostasis are important to ensure a dry field and to avoid inadvertent damage to the adjacent structures. The two most common techniques for hemostasis are suture ligatures and electrocoagulation. The use of electrocoagulation (EC) to control bleeding has the potential risk of injuring the surrounding structures from lateral dispersion of heat. New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

Conditions

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Benign Thyroid Disease

Keywords

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Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy under general anesthesia is indicated

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Harmonic

Group operated with Harmonic device

No interventions assigned to this group

Conventional

Group operated with Electrocauery and Clip/Suture

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Elected to undergo total thyroidectomy.
* Able to comprehend and sign the applicable study informed consent form.
* Able to return for all study mandated visits (visit 1 and 2)
* Be greater than or equal to 18 years of age.

Exclusion Criteria

* Previous neck operation
* History of neck irritation
* Need for central or lateral compartment lymphadenectomy
* Patients under permanent pain killer medication
* Patients under anticoagulation medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery (Europe) GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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University of Pisa

Locations

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CHU Sart-Tilman

Liège, , Belgium

Site Status

University of Pisa

Pisa, , Italy

Site Status

Countries

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Belgium Italy

Other Identifiers

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EO-0469

Identifier Type: -

Identifier Source: secondary_id

CME-07-001

Identifier Type: -

Identifier Source: org_study_id