NCT00666315

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Ethicon Endo-Surgery (Europe) GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Benign Thyroid Disease

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2008-04-24
• Last updated: 2008-05-22

Locations

2 sites across 2 countries: Belgium, Italy