Overview

This trial is active, not recruiting.

Condition multinodular goiter
Treatments ace14s, harmonic focus®
Sponsor Hospital Universitari de Bellvitge
Start date February 2009
End date March 2010
Trial size 56 participants
Trial identifier NCT01658085, EO-0618

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
harmonic focus® FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
ace14s ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA)
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S

Primary Outcomes

Measure
Operative time
time frame: Surgical time from skin incision to closure (about 70 minutes)

Secondary Outcomes

Measure
Total and relative (%) time of use of the device along thyroidectomy
time frame: From skin incision to removal of thyroid gland (about 30 minutes)
Recurrent laryngeal nerve (RLN) injury
time frame: From surgery to 6 months
hypocalcemia (both persistent or temporary)
time frame: Daily, from surgery to discharge (24h), or up to 6 months
postoperative pain according to a visual scale of pain
time frame: From surgery to 7 days
QOL after thyroidectomy (EuroQOL)
time frame: 1st and 7th postoperative day
Number of ligatures
time frame: Day of surgery
Length of skin incision
time frame: Day of surgery
budget impact analysis
time frame: From surgery to discharge (24h)

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study
Principal investigator Pablo Moreno, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Hospital Universitari de Bellvitge.