We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649154
First Posted: July 25, 2012
Last Update Posted: July 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giulia Cosenza, Ospedale Regina Apostolorum
  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
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Further study details as provided by Giulia Cosenza, Ospedale Regina Apostolorum:

Primary Outcome Measures:
  • Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.

Secondary Outcome Measures:
  • Cost assessment of new generation devices in thyroid surgery

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • thyroid benign disease

Exclusion Criteria:

  • malignant disease
  • thyroid malign disease requiring lymphadenectomy
  • coagulatory disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649154


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

Responsible Party: Giulia Cosenza, Principal Investigator, Ospedale Regina Apostolorum
ClinicalTrials.gov Identifier: NCT01649154     History of Changes
Other Study ID Numbers: 8580/DS/CE
First Submitted: June 24, 2012
First Posted: July 25, 2012
Last Update Posted: July 25, 2012
Last Verified: June 2012