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Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy

NCT ID: NCT01649154

Last Updated: 2012-07-25

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

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.

Detailed Description

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A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.

Conditions

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Benign Thoroid Disease Requiring Total Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ligasure Small-JAW

Group Type ACTIVE_COMPARATOR

Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Intervention Type PROCEDURE

Harmonic Focus

Group Type ACTIVE_COMPARATOR

Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Intervention Type PROCEDURE

Clamp-and-Tie technique

Group Type ACTIVE_COMPARATOR

Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Intervention Type PROCEDURE

Interventions

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Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* thyroid benign disease

Exclusion Criteria

* malignant disease
* thyroid malign disease requiring lymphadenectomy
* coagulatory disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Regina Apostolorum

OTHER

Sponsor Role lead

Responsible Party

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Giulia Cosenza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Regina Apostolorum

Albano Laziale, Rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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8580/DS/CE

Identifier Type: -

Identifier Source: org_study_id