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

Benign Thoroid Disease Requiring Total Thyroidectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649154
• Other study ID #: 8580/DS/CE
• Status: Completed
• Phase: N/A
• First received: June 24, 2012
• Last updated: July 20, 2012
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Ospedale Regina Apostolorum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Institutional Review Board (Comitato Etico Ospedale Regina Apostolorum, Albano Laziale)Italy: Regione Lazio, ASL Roma HItaly: Ministery of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• thyroid benign disease

Exclusion Criteria:

• malignant disease

• thyroid malign disease requiring lymphadenectomy

• coagulatory disease

Study Design

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

Related Conditions & MeSH terms

• Benign Thoroid Disease Requiring Total Thyroidectomy

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Regina Apostolorum	Albano Laziale	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Regina Apostolorum

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.			Yes
Secondary	Cost assessment of new generation devices in thyroid surgery			Yes