Total Thyroidectomy With Harmonic Scalpel®

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00385983
• Other study ID #: CP005
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: October 10, 2006

Study information

• Verified date: October 2006
• Source: Brazilian Society of Head and Neck Surgery
• Contact: Luiz P Kowalski, PhD
• Phone: 55-11-33410325
• Email: lp_kowalski[@]uol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Goiter
• Thyroid Diseases
• Thyroid Neoplasm
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Device:
• Harmonic Scalpel

Locations

Country	Name	City	State
Brazil	Hospital Erasto Gaertner	Curitiba	PR
Brazil	Hospital Araujo Jorge	Goiania	GO
Brazil	Hospital do Cancer de Natal	Natal	RN
Brazil	Instituto Nacional de Cancer INCA	Rio de Janeiro	RJ
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

Sponsors (2)

Lead Sponsor	Collaborator
Brazilian Society of Head and Neck Surgery	Johnson & Johnson

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications
Secondary	Operative time
Secondary	Drainage volume
Secondary	Postoperative pain
Secondary	Length of stay
Secondary	Direct Costs