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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giulia Cosenza, Ospedale Regina Apostolorum
ClinicalTrials.gov Identifier:
NCT01649154
First received: June 24, 2012
Last updated: July 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Benign Thoroid Disease Requiring Total Thyroidectomy
 Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by Ospedale Regina Apostolorum:

Primary Outcome Measures:
  • Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost assessment of new generation devices in thyroid surgery [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ligasure Small-JAW Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
Active Comparator: Harmonic Focus Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
Active Comparator: Clamp-and-Tie technique Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • thyroid benign disease

Exclusion Criteria:

  • malignant disease
  • thyroid malign disease requiring lymphadenectomy
  • coagulatory disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649154

Locations
Italy
Ospedale Regina Apostolorum
Albano Laziale, Rome, Italy, 00041
Sponsors and Collaborators
Ospedale Regina Apostolorum
  More Information

No publications provided

Responsible Party: Giulia Cosenza, Principal Investigator, Ospedale Regina Apostolorum
ClinicalTrials.gov Identifier: NCT01649154     History of Changes
Other Study ID Numbers: 8580/DS/CE
Study First Received: June 24, 2012
Last Updated: July 20, 2012
Health Authority: Italy: Institutional Review Board (Comitato Etico Ospedale Regina Apostolorum, Albano Laziale)
Italy: Regione Lazio, ASL Roma H
Italy: Ministery of Health

ClinicalTrials.gov processed this record on May 22, 2013