Total Thyroidectomy With Harmonic Scalpel®

Phase 4

• Conditions: Thyroid Neoplasm; Goiter; Thyroid Nodule

• Registration Number: NCT00385983
• Lead Sponsor: Brazilian Society of Head and Neck Surgery

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.

Study Timeline

• Status Verified: 2006-10
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Last Update Submitted: 2006-10-10
• Study First Posted: 2006-10-11
• Last Update Posted: 2006-10-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative complications

Secondary Outcome Measures

Name	Time	Method
Operative time
Drainage volume
Postoperative pain
Length of stay
Direct Costs

Trial Locations

Locations (9)

Santa Casa de Misericordia; 🇧🇷 Sao Paulo, SP, Brazil

Hospital do Cancer AC Camargo; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Sao Paulo-UNIFESP; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Araujo Jorge; 🇧🇷 Goiania, GO, Brazil

Hospital do Cancer de Natal; 🇧🇷 Natal, RN, Brazil

Instituto Arnaldo Vieira de Carvalho; 🇧🇷 Sao Paulo, SP, Brazil

Instituto Nacional de Cancer INCA; 🇧🇷 Rio de Janeiro, RJ, Brazil

Hospital Erasto Gaertner; 🇧🇷 Curitiba, PR, Brazil

Hospital Heliopolis; 🇧🇷 Sao Paulo, SP, Brazil