Budget Impact of Harmonic FOCUS in Thyroidectomy

Multinodular Goiter Clinical Trial

— TIME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01658085
• Other study ID #: EO-0618
• Status: Active, not recruiting
• Phase: N/A
• First received: July 17, 2012
• Last updated: August 1, 2012
• Start date: February 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: August 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multinodular Goiter

Intervention

Device:
• ACE14S
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
• HARMONIC FOCUS®
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®

Locations

Country	Name	City	State
Spain	Hospital UIniversitari de Bellvitge	L'Hospitalet	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Length of skin incision	Measured at the end of the operation, once the skin was closured.	Day of surgery	No
Secondary	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)	No