Benign Thoroid Disease Requiring Total Thyroidectomy
Conditions
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.
Interventions
PROCEDURETotal Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus
Sponsors
Ospedale Regina Apostolorum
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Inclusion criteria
* thyroid benign disease
Exclusion criteria
* malignant disease * thyroid malign disease requiring lymphadenectomy * coagulatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost assessment of new generation devices in thyroid surgery | — |
Countries
Italy
Outcome results
None listed