- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666315
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease
May 21, 2008 updated by: Ethicon Endo-Surgery (Europe) GmbH
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease -A Prospective, Comparative, Multicenter, Observational Study
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy under general anesthesia is indicated.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Harmonic
Group operated with Harmonic device
|
Conventional
Group operated with Electrocauery and Clip/Suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time incision to skin closure
Time Frame: during surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications
Time Frame: intra- and postoperative
|
intra- and postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 23, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Estimate)
May 22, 2008
Last Update Submitted That Met QC Criteria
May 21, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CME-07-001
- EO-0469
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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