Total Thyroidectomy With Harmonic Scalpel®
Conditions
Thyroid Neoplasm - Goiter - Thyroid Nodule
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms - Thyroid Nodule
Conditions: Keywords
thyroidectomy, thyroid neoplasm, postoperative complications, cost effectiveness
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Intervention
Name: Harmonic Scalpel
Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult (>18 y/o)

- Benign or malignant thyroid disease

- Proposal of total thyroidectomy

- Normal thyroid function

Exclusion Criteria:

- Giant goiter

- Hyperthyroidism

- Non differentiated thyroid carcinoma

- Locally invasive tumors

- Neck dissection as a part of procedure

- Previous surgery, radiotherapy or I131 therapy on neck

- Video-assisted or endoscopic thyroidectomy

- Severe comorbidities

- Coagulation disorders
Locations
Hospital Araujo Jorge
Goiania, GO, Brazil
Status: Not yet recruiting
Hospital Erasto Gaertner
Curitiba, PR, Brazil
Status: Not yet recruiting
Instituto Nacional de Cancer INCA
Rio de Janeiro, RJ, Brazil
Status: Not yet recruiting
Hospital do Cancer de Natal
Natal, RN, Brazil
Status: Not yet recruiting
Hospital do Cancer AC Camargo
Sao Paulo, SP, Brazil
Status: Not yet recruiting
Hospital Heliopolis
Sao Paulo, SP, Brazil
Status: Not yet recruiting
Hospital Sao Paulo-UNIFESP
Sao Paulo, SP, Brazil
Status: Not yet recruiting
Instituto Arnaldo Vieira de Carvalho
Sao Paulo, SP, Brazil
Status: Not yet recruiting
Santa Casa de Misericordia
Sao Paulo, SP, Brazil
Status: Not yet recruiting
Sponsors
Brazilian Society of Head and Neck Surgery
Source
Brazilian Society of Head and Neck Surgery
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page