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


Phase 4
18 Years
N/A
Not Enrolling
Both
Thyroid Neoplasm, Goiter, Thyroid Nodule

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Postoperative complications

Principal Investigator

Luiz P Kowalski, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brazilian Society of Head and Neck Surgery

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

CP005

NCT ID:

NCT00385983

Start Date:

Completion Date:

Related Keywords:

  • Thyroid Neoplasm
  • Goiter
  • Thyroid Nodule
  • thyroidectomy
  • thyroid neoplasm
  • postoperative complications
  • cost effectiveness
  • Neoplasms
  • Thyroid Neoplasms
  • Goiter
  • Thyroid Diseases
  • Thyroid Nodule

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