Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier:
NCT00666315
First received: April 22, 2008
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.


Condition
Benign Thyroid Disease

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 Prospective, Comparative, Multicenter, Observational Study

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery (Europe) GmbH:

Primary Outcome Measures:
  • Time incision to skin closure [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: intra- and postoperative ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Harmonic
Group operated with Harmonic device
Conventional
Group operated with Electrocauery and Clip/Suture

Detailed Description:

Thyroidectomy is one of the most frequently performed operations in endocrine surgery. Results are generally excellent, and morbidity and mortality are usually negligible. The operation requires proper identification of important structures such as the recurrent laryngeal nerve (RLN) and the parathyroid glands. Meticulous dissection and exhaustive hemostasis are important to ensure a dry field and to avoid inadvertent damage to the adjacent structures. The two most common techniques for hemostasis are suture ligatures and electrocoagulation. The use of electrocoagulation (EC) to control bleeding has the potential risk of injuring the surrounding structures from lateral dispersion of heat. New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy under general anesthesia is indicated.

Criteria

Inclusion Criteria:

  • Elected to undergo total thyroidectomy.
  • Able to comprehend and sign the applicable study informed consent form.
  • Able to return for all study mandated visits (visit 1 and 2)
  • Be greater than or equal to 18 years of age.

Exclusion Criteria:

  • Previous neck operation
  • History of neck irritation
  • Need for central or lateral compartment lymphadenectomy
  • Patients under permanent pain killer medication
  • Patients under anticoagulation medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666315

Locations
Belgium
CHU Sart-Tilman
Liege, Belgium
Italy
University of Pisa
Pisa, Italy
Sponsors and Collaborators
Ethicon Endo-Surgery (Europe) GmbH
  More Information

No publications provided

Responsible Party: Prof. Dr. Miccoli, University of Pisa
ClinicalTrials.gov Identifier: NCT00666315     History of Changes
Other Study ID Numbers: CME-07-001, EO-0469
Study First Received: April 22, 2008
Last Updated: May 21, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Ethicon Endo-Surgery (Europe) GmbH:
Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy under general anesthesia is indicated

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014