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

Not Applicable

Completed

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

• Registration Number: NCT01649154
• Lead Sponsor: Ospedale Regina Apostolorum

Brief 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.

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-24
• Study First Submitted QC: 2012-07-20
• Last Update Submitted: 2012-07-20
• Study First Posted: 2012-07-25
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• thyroid benign disease

Exclusion Criteria

• malignant disease
• thyroid malign disease requiring lymphadenectomy
• coagulatory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Ligasure Small-JAW	Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus	-
Harmonic Focus	Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus	-
Clamp-and-Tie technique	Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus	-

Primary Outcome Measures

Name	Time	Method
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.

Secondary Outcome Measures

Name	Time	Method
Cost assessment of new generation devices in thyroid surgery

Trial Locations

Locations (1)

Ospedale Regina Apostolorum; 🇮🇹 Albano Laziale, Rome, Italy