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Spots Global Cancer Trial Database for Total Thyroidectomy With Harmonic Scalpel®

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

Harmonic Scalpel

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Luiz P Kowalski, PhD

Affiliation: Brazilian Society of Head and Neck Surgery

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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