Budget Impact of Harmonic FOCUS in Thyroidectomy

NCT01658085 | Unknown DMC

• 1 other identifier: EO-0618
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Multinodular Goiter

Keywords

Thyroidectomy; Multinodular goiter; Harmonic Focus; budget impact; Harmonic scalpel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total and relative (%) time of use of the device along thyroidectomy

  From skin incision to removal of thyroid gland (about 30 minutes)

• Recurrent laryngeal nerve (RLN) injury

  From surgery to 6 months

• hypocalcemia (both persistent or temporary)

  Daily, from surgery to discharge (24h), or up to 6 months

• postoperative pain according to a visual scale of pain

  From surgery to 7 days

• QOL after thyroidectomy (EuroQOL)

  1st and 7th postoperative day

Study Arms (2)

Study group: HARMONIC FOCUS®

Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®

Device: HARMONIC FOCUS®

Control group: ACE14S

Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S

Device: ACE14S

Interventions

ACE14S DEVICE

Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S

Also known as: ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA)

Control group: ACE14S

HARMONIC FOCUS® DEVICE

Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®

Also known as: FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)

Study group: HARMONIC FOCUS®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Multinodular goiter (MNG), age between 18 and 80 and consent to be included in the study

You may not qualify if:

• previous neck surgery
• vocal fold impairment
• permanent or transitory NSAID or analgesic treatment,
• coagulation disorders
• any cognitive impairment.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital UIniversitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Officials

• Pablo Moreno, MD, PhD

  Hospital UIniversitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief endocrine Surgery Unit

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 6, 2012
• Study Start: February 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2012
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

ES (1)