Multinodular Goiter Clinical Trial
Official title:
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study
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 to the surgeon previous to start surgery. Medical
staff of the Endocrine Surgery Unit collected clinical data.
Surgical Technique Total thyroidectomy (TT), defined as total bilateral extracapsular
lobectomy 9, was performed using HF or ACE14S for vessel division. Monopolar and bipolar
forceps for cutting and coagulation were routinely used. Ties were used under surgeon's
criteria according to size of the vessels and/or the need to obtain haemostasis in the
vicinity of the RLN when bipolar forceps were not considered safe enough.
OBJECTIVE:
To disclose the potential advantages and outcomes of the new Harmonic Focus (HF) device
compared to Harmonic Scalpel ACE14S (ACE-14S) in benign thyroid surgery.
STUDY DESIGN:
Controlled randomized study.
METHODS:
Harmonic Focus was compared to former ACE14S device in patients undergoing total
thyroidectomy for Multinodular Goiter. The primary endpoint was time of surgery. Secondary
endpoints were time of use of the device, % of use along the procedure, number of ligatures,
blood loss, hypocalcaemia, recurrent laryngeal nerve impairment, postoperative pain and
quality of life.
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Observational Model: Case Control, Time Perspective: Prospective
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