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

NCT00666315 | Completed

• 2 other identifiers: CME-07-001EO-0469
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Benign Thyroid Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time incision to skin closure

  during surgery

Secondary Outcomes (1)

• Complications

  intra- and postoperative

Study Arms (2)

Harmonic

Group operated with Harmonic device

Conventional

Group operated with Electrocauery and Clip/Suture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Previous neck operation
• History of neck irritation
• Need for central or lateral compartment lymphadenectomy
• Patients under permanent pain killer medication
• Patients under anticoagulation medication

Sponsors & Collaborators

• Ethicon Endo-Surgery (Europe) GmbH: lead

Study Sites (2)

CHU Sart-Tilman

Liège, Belgium

Location

University of Pisa

Pisa, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

IT (1); BE (1)