Budget Impact of Harmonic FOCUS in Thyroidectomy

Study Overview
=================
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 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study

Conditions
-----------------
Multinodular Goiter

Intervention / Treatment
-----------------
* Device: ACE14S
* Device: HARMONIC FOCUS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multinodular goiter (MNG), age between 18 and 80 and consent to be included in the study Exclusion Criteria: previous neck surgery vocal fold impairment permanent or transitory NSAID or analgesic treatment, coagulation disorders any cognitive impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group: HARMONIC FOCUS®<br>Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS® | Device: HARMONIC FOCUS®<br>* Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®<br>* Other names: FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA);|
| Control group: ACE14S<br>Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S | Device: ACE14S<br>* Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S<br>* Other names: ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time was measured from skin incision to removal of thyroid gland. The percentage of time using the device along TT was calculated as follows: time of use of the device x 100/ operative time. | Surgical time from skin incision to closure (about 70 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total and relative (%) time of use of the device along thyroidectomy | The percentage of time using the device along surgery was calculated as follows: time of use of the device x 100/ operative time. | From skin incision to removal of thyroid gland (about 30 minutes) | 
| Recurrent laryngeal nerve (RLN) injury | Patients with laryngeal nerve injury were controlled monthly by indirect laryngoscopy till 6 months or healing. | From surgery to 6 months | 
| hypocalcemia (both persistent or temporary) | Temporary hypocalcemia was measured daily, from surgery to discharge. Persistent hypocalcemia was followed up as follows: Non-complicated patients: one week and six months after the operation date. Complicated patients: every month until cure or up to 6 months after surgery. | Daily, from surgery to discharge (24h), or up to 6 months | 
| postoperative pain according to a visual scale of pain | Pain evaluation was obtained at 24h and 7 days after surgery during postoperative control by using an analogue-visual scale reporting also the type of analgesic and the number of doses. If there was any complication (including reoperation) that increased hospital stay, pain evaluation was performed each 24h until discharge. | From surgery to 7 days | 
| QOL after thyroidectomy (EuroQOL) | QOL was evaluated by completing EQ-5D questionnaire when patients were scheduled for the study (1st and 7th postoperative day) | 1st and 7th postoperative day | 
| Number of ligatures | Number of ligatures during the procedure was measured to determine if its reduction would imply less surgical time consumption | Day of surgery | 
| Length of skin incision | Measured at the end of the operation, once the skin was closured. | Day of surgery | 
| budget impact analysis | costs of total thyroidectomy (all of them according to the prices of our center) and deducting those time-dependent costs saved with the reduction of OR time. The following concepts were considered: personnel (with the same surgical team composition for both alternatives), anesthesia drugs, medical devices, overheads, repayment of the Harmonic generator, hospital stay and admission/discharge fees. | From surgery to discharge (24h) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroidectomy, Multinodular goiter, Harmonic Focus, budget impact, Harmonic scalpel