Clinical trial NCT00385983: Total Thyroidectomy With Harmonic Scalpel®
Official title: Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thyroid Neoplasm
Goiter
Thyroid Nodule
Keywords: thyroidectomy
thyroid neoplasm
postoperative complications
cost effectiveness
Lead sponsor: Brazilian Society of Head and Neck Surgery
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2006-10-11
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Postoperative complications
Secondary outcomes:
measure: Operative time
measure: Drainage volume
measure: Postoperative pain
measure: Length of stay
measure: Direct Costs
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: GO
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: PR
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer INCA
state: RJ
city: Natal
country: Brazil
facility: Hospital do Cancer de Natal
state: RN
city: Sao Paulo
country: Brazil
facility: Hospital do Cancer AC Camargo
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Heliopolis
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo-UNIFESP
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Arnaldo Vieira de Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Santa Casa de Misericordia
state: SP
Study officials:
affiliation: Brazilian Society of Head and Neck Surgery
name: Luiz P Kowalski, PhD
role: PRINCIPAL_INVESTIGATOR
References: