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

Benign Thyroid Disease Clinical Trial

Official title:

Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease -A Prospective, Comparative, Multicenter, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666315
• Other study ID #: CME-07-001
• Secondary ID: EO-0469
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: May 21, 2008
• Start date: December 2007
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Ethicon Endo-Surgery (Europe) GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Thyroid Disease
• Thyroid Diseases

Locations

Country	Name	City	State
Belgium	CHU Sart-Tilman	Liege
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery (Europe) GmbH

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time incision to skin closure		during surgery	No
Secondary	Complications		intra- and postoperative	No