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

Sponsors

Lead Sponsor: Ospedale Regina Apostolorum

Source 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.

Overall Status Completed
Start Date 2011-04-01
Completion Date 2012-05-01
Primary Completion Date 2012-04-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
Secondary Outcome
Measure Time Frame
Cost assessment of new generation devices in thyroid surgery
Enrollment 120
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus

Eligibility

Criteria:

Inclusion Criteria: - thyroid benign disease Exclusion Criteria: - malignant disease - thyroid malign disease requiring lymphadenectomy - coagulatory disease

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Location
Facility: Ospedale Regina Apostolorum
Location Countries

Italy

Verification Date

2012-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ospedale Regina Apostolorum

Investigator Full Name: Giulia Cosenza

Investigator Title: Principal Investigator

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Ligasure Small-JAW

Type: Active Comparator

Label: Harmonic Focus

Type: Active Comparator

Label: Clamp-and-Tie technique

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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