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

June 24, 2012
July 20, 2012
April 2011
April 2012   (final data collection date for primary outcome measure)
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy. [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01649154 on ClinicalTrials.gov Archive Site
Cost assessment of new generation devices in thyroid surgery [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
  • Active Comparator: Ligasure Small-JAW
    Intervention: 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
    Intervention: 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
    Intervention: Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • thyroid benign disease

Exclusion Criteria:

  • malignant disease
  • thyroid malign disease requiring lymphadenectomy
  • coagulatory disease
Both
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01649154
8580/DS/CE
No
Giulia Cosenza, Ospedale Regina Apostolorum
Ospedale Regina Apostolorum
Not Provided
Not Provided
Ospedale Regina Apostolorum
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP