Budget Impact of Harmonic FOCUS in Thyroidectomy (TIME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hospital Universitari de Bellvitge.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Pablo Moreno Llorente, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01658085
First received: July 17, 2012
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Multinodular Goiter
Device: ACE14S
Device: HARMONIC FOCUS®

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease. A Randomized, Prospective Study

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Operative time [ Time Frame: Surgical time from skin incision to closure (about 70 minutes) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Total and relative (%) time of use of the device along thyroidectomy [ Time Frame: From skin incision to removal of thyroid gland (about 30 minutes) ] [ Designated as safety issue: Yes ]
    The percentage of time using the device along surgery was calculated as follows: time of use of the device x 100/ operative time.

  • Recurrent laryngeal nerve (RLN) injury [ Time Frame: From surgery to 6 months ] [ Designated as safety issue: Yes ]
    Patients with laryngeal nerve injury were controlled monthly by indirect laryngoscopy till 6 months or healing.

  • hypocalcemia (both persistent or temporary) [ Time Frame: Daily, from surgery to discharge (24h), or up to 6 months ] [ Designated as safety issue: Yes ]

    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.

  • postoperative pain according to a visual scale of pain [ Time Frame: From surgery to 7 days ] [ Designated as safety issue: Yes ]
    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.

  • QOL after thyroidectomy (EuroQOL) [ Time Frame: 1st and 7th postoperative day ] [ Designated as safety issue: No ]
    QOL was evaluated by completing EQ-5D questionnaire when patients were scheduled for the study (1st and 7th postoperative day)

  • Number of ligatures [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Number of ligatures during the procedure was measured to determine if its reduction would imply less surgical time consumption

  • Length of skin incision [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    Measured at the end of the operation, once the skin was closured.

  • budget impact analysis [ Time Frame: From surgery to discharge (24h) ] [ Designated as safety issue: No ]
    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.


Enrollment: 56
Study Start Date: February 2009
Estimated Study Completion Date: August 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study group: HARMONIC FOCUS®
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
Device: HARMONIC FOCUS®
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
Other Name: FOCUS Curved Shear, Code:FCS9 (EES, Cincinnati, OH, USA)
Control group: ACE14S
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
Device: ACE14S
Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
Other Name: ACE® Curved Shears, Code: ACE14S (EES, Cincinnati, OH, USA)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01658085

Locations
Spain
Hospital UIniversitari de Bellvitge
L'Hospitalet, Barcelona, Spain, 08907
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Pablo Moreno, MD, PhD Hospital UIniversitari de Bellvitge
  More Information

No publications provided

Responsible Party: Pablo Moreno Llorente, Chief endocrine Surgery Unit, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01658085     History of Changes
Other Study ID Numbers: EO-0618
Study First Received: July 17, 2012
Last Updated: August 1, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Thyroidectomy
Multinodular goiter
Harmonic Focus
budget impact
Harmonic scalpel

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014