Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ospedale Regina Apostolorum
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •thyroid benign disease
Exclusion Criteria
- •malignant disease
- •thyroid malign disease requiring lymphadenectomy
- •coagulatory disease
Outcomes
Primary Outcomes
Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy.
Secondary Outcomes
- Cost assessment of new generation devices in thyroid surgery
Investigators
Giulia Cosenza
Principal Investigator
Ospedale Regina Apostolorum