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Brief Title: Total Thyroidectomy With Harmonic Scalpel®
Official Title: Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial
Study ID: NCT00385983
Brief Summary: Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures. Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications
Detailed Description: This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Araujo Jorge, Goiania, GO, Brazil
Hospital Erasto Gaertner, Curitiba, PR, Brazil
Instituto Nacional de Cancer INCA, Rio de Janeiro, RJ, Brazil
Hospital do Cancer de Natal, Natal, RN, Brazil
Hospital do Cancer AC Camargo, Sao Paulo, SP, Brazil
Hospital Heliopolis, Sao Paulo, SP, Brazil
Hospital Sao Paulo-UNIFESP, Sao Paulo, SP, Brazil
Instituto Arnaldo Vieira de Carvalho, Sao Paulo, SP, Brazil
Santa Casa de Misericordia, Sao Paulo, SP, Brazil
Name: Luiz P Kowalski, PhD
Affiliation: Brazilian Society of Head and Neck Surgery
Role: PRINCIPAL_INVESTIGATOR