Total Thyroidectomy With Harmonic Scalpel®

Study Overview
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Brief Summary
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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
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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.

Official Title
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Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial

Conditions
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Goiter, Thyroid Neoplasm, Thyroid Nodule

Intervention / Treatment
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* Device: Harmonic Scalpel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Harmonic Scalpel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  |  | 
| Drainage volume |  |  | 
| Postoperative pain |  |  | 
| Length of stay |  |  | 
| Direct Costs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, thyroid neoplasm, postoperative complications, cost effectiveness