Multinodular GoiterTIMENCT01658085
Budget Impact of Harmonic FOCUS in Thyroidectomy
An observational study of Multinodular Goiter, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multinodular Goiter
- What is being tested?
- ACE14S and HARMONIC FOCUS®
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Multinodular goiter (MNG), age between 18 and 80 and consent to be included in the study
Who cannot join
- previous neck surgery
- vocal fold impairment
- permanent or transitory NSAID or analgesic treatment,
- coagulation disorders
- any cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital UIniversitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Multinodular Goiter
- Being tested
- ACE14S, HARMONIC FOCUS®
- Keywords
- Thyroidectomy, Multinodular goiter, Harmonic Focus, budget impact, Harmonic scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE14SDevice
Also called ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA)
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
HARMONIC FOCUS®Device
Also called FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
| Study group | Role | What they receive |
|---|---|---|
| Study group: HARMONIC FOCUS® | Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS® Receives: Device: HARMONIC FOCUS® | |
| Control group: ACE14S | Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S Receives: Device: ACE14S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Surgical time from skin incision to closure (about 70 minutes)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: Day of surgery
Length of skin incision
Measured at the end of the operation, once the skin was closured.
Measured: 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.
Measured: From surgery to discharge (24h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multinodular GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Moreno Llorente, Hospital Universitari de Bellvitge
- Investigators
- Pablo Moreno, MD, PhD, Principal investigator, Hospital UIniversitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658085
- Sponsor's protocol ID
- EO-0618
- Acronym
- TIME
- Status last verified
- Aug 2012
- First submitted
- 17 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT01658085
- Acronym / sponsor ID
- TIME / EO-0618
- Conditions
- Multinodular Goiter
- Keywords
- Thyroidectomy, Multinodular goiter, Harmonic Focus, budget impact, Harmonic scalpel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2012 (estimated)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: HARMONIC FOCUS® | – | Device: HARMONIC FOCUS®Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS® |
| Control group: ACE14S | – | Device: ACE14STotal thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Multinodular goiter (MNG), age between 18 and 80 and consent to be included in the study
Key exclusion criteria (5 listed)
- previous neck surgery
- vocal fold impairment
- permanent or transitory NSAID or analgesic treatment,
- coagulation disorders
- any cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE14SAlso: ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA)Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S | Device | Control group: ACE14S |
| HARMONIC FOCUS®Also: FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS® | Device | Study group: HARMONIC FOCUS® |
Primary outcome
Operative time
Time frame: Surgical time from skin incision to closure (about 70 minutes)
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.
8 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Moreno, MD, PhD principal investigator
Hospital UIniversitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multinodular Goiter, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Surgical time from skin incision to closure (about 70 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.