Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study
Brief Summary:
Study Design Multinodular Goiter (MNG) patients requiring surgery were referred to the Endocrine Surgery Unit.
Indirect laryngoscopy was routinely performed preoperatively to assess normal motility in vocal folds (VF). Ultrasounds (US) study was performed the month previous to surgery to evaluate thyroid volume. Eligible patients met the following criteria: to have MNG, age between 18 and 80 and consent to be included in the study. Exclusion criteria included previous neck surgery, vocal fold impairment, permanent or transitory NSAID or analgesic treatment, coagulation disorders and any cognitive impairment.
Eligible patients were proposed to enter a randomized study with 2 arms in which we compared the use of two harmonic scalpel devices: ACE14S and Harmonic Focus (Ethicon Endo-Surgery, Cincinnati, OH, USA).
The main endpoint was operative time. Secondary endpoints were total and relative (%) time of use of the device along thyroidectomy, recurrent laryngeal nerve (RLN) injury and hypocalcaemia (both persistent or temporary), number of ligatures, length of skin incision, postoperative pain according to a visual scale of pain, QOL after thyroidectomy (EuroQOL) and budget impact analysis.
All patients were operated on by 2 surgeons, one senior (responsible for the Endocrine Surgery Unit) and one junior under supervision.
Randomization Randomization was performed the same day of surgery at the OR by using a closed envelope. Patients were randomized to Group I (ACE14S) or Group II (HF) and allocated in a 1:1 proportion; they reminded blinded until the end of the study about the device used.
The haemostasis device was communicated