Clinical trial NCT01658085: Budget Impact of Harmonic FOCUS in Thyroidectomy
Official title: Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multinodular Goiter
Keywords: Thyroidectomy
Multinodular goiter
Harmonic Focus
budget impact
Harmonic scalpel
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Operative time
timeFrame: Surgical time from skin incision to closure (about 70 minutes)
Secondary outcomes:
measure: Total and relative (%) time of use of the device along thyroidectomy
timeFrame: From skin incision to removal of thyroid gland (about 30 minutes)
measure: Recurrent laryngeal nerve (RLN) injury
timeFrame: From surgery to 6 months
measure: hypocalcemia (both persistent or temporary)
timeFrame: Daily, from surgery to discharge (24h), or up to 6 months
measure: postoperative pain according to a visual scale of pain
timeFrame: From surgery to 7 days
measure: QOL after thyroidectomy (EuroQOL)
timeFrame: 1st and 7th postoperative day
measure: Number of ligatures
timeFrame: Day of surgery
measure: Length of skin incision
timeFrame: Day of surgery
measure: budget impact analysis
timeFrame: From surgery to discharge (24h)
Other outcomes:
Locations:
city: L'Hospitalet
country: Spain
facility: Hospital UIniversitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital UIniversitari de Bellvitge
name: Pablo Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: