Budget Impact of Harmonic FOCUS in Thyroidectomy (TIME)

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.

Study Overview

• Status: Unknown
• Conditions: Multinodular Goiter
• Intervention / Treatment: Device: HARMONIC FOCUS®; Device: ACE14S

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet, Barcelona, Spain, 08907
      • Hospital UIniversitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible patients met the following criteria: to have MNG, age between 18 and 80 and consent to be included in the study.

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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group: HARMONIC FOCUS®; Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®	Device: HARMONIC FOCUS®; Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®; Other Names: FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)
Control group: ACE14S; Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S	Device: ACE14S; Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S; 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)

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Pablo Moreno, MD, PhD, Hospital UIniversitari de Bellvitge

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 1, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Thyroidectomy; Multinodular goiter; Harmonic scalpel; Harmonic Focus; budget impact
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Goiter
• Other Study ID Numbers: EO-0618