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Subtotal Versus Total Thyroidectomy for Graves' Disease

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT01408368
First received: August 2, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

The extent of thyroid resection in Graves' disease remains controversial. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with Graves' ophthalmopathy.


Condition Intervention
Thyroid
Goiter
Procedure: Bilateral subtotal thyroidectomy
Procedure: Total thyroidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • Long-term control of Graves' disease [ Time Frame: up to 60 months postoperatively ] [ Designated as safety issue: Yes ]
    Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy


Secondary Outcome Measures:
  • Morbidity rate [ Time Frame: up to 12 months postoperatively ] [ Designated as safety issue: Yes ]
    recurrent laryngeal nerve injury and hypoparathyroidism


Enrollment: 200
Study Start Date: January 2000
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bilateral subtotal thyroidectomy Procedure: Bilateral subtotal thyroidectomy
The intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each).
Other Name: BST
Experimental: Total thyroidectomy Procedure: Total thyroidectomy
The intervention consisted of total extracapsular thyroidectomy.
Other Name: TT

Detailed Description:

Graves' disease was first described in 1835. It is an autoimmune disorder caused by antibodies which bind to thyroid-stimulating hormone (TSH) receptors on the thyroid cell membrane. The overt clinical manifestation of this disease is usually characterised by presence of hyperthyroidism, thyroid associated ophthalmopathy and thyroid dermopathy.

Treatment alternatives of Graves' disease include antithyroid medication, radioiodine therapy or thyroidectomy. The antithyroid medication is often used as the initial treatment for patients with newly diagnosed Graves disease in much of the world including Europe, Japan and South America. However, the use of radioiodine is the most common first-line treatment modality in the United States. Thyroidectomy should be considered in special circumstances such as in children and young adults, pregnant women, in the setting of ophthalmopathy, in the presence of thyroid nodules or big goitre, particularly when compressive symptoms, or substernal thyroid extension is diagnosed, as well as in cases of failed hyperthyroidism remission after antithyroid medication in patients refusing possible radioiodine treatment.

The surgical management of Graves' disease remains controversial. Some authors support total thyroidectomy while others prefer various subtotal procedures. Most low-volume surgeons avoid performing total thyroidectomies for Graves' disease owing to the assumed higher complication rates. On the other hand, an increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indications for this procedure include not only high-risk thyroid cancer, but also Graves's disease and multinodular goiter. It has been shown that total thyroidectomy for Graves' disease lowers to almost zero the disease recurrence rate. However, other issues like unclear benefit for natural course of Graves' ophthalmopathy balanced against assumed higher risk of morbidity following more radical thyroid resections need to be clarified.

We hypothesized that total thyroidectomy is superior to bilateral subtotal thyroidectomy for long-term control of Graves' disease. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with mild and active Graves' ophthalmopathy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned thyroid surgery for clinically, biochemically and immunologically diagnosed Graves' disease in patients with mild active ophthalmopathy and the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

Exclusion Criteria:

  • previous thyroid or parathyroid surgery,
  • recurrent hyperthyroidism after radioiodine ablation,
  • history of Graves' disease longer than 24 months,
  • thyroid nodules within the posterior aspect/s of thyroid lobe/s,
  • suspicion of thyroid cancer,
  • inactive Graves' ophthalmopathy,
  • moderate to severe active Graves' ophthalmopathy,
  • preoperative recurrent laryngeal nerve palsy,
  • pregnancy or lactation,
  • age < 18 years, or > 65 years,
  • ASA 4 grade (American Society of Anaesthesiology),
  • inability to comply with the follow-up protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408368

Locations
Poland
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Krakow, Poland, 31-202
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University, Medical College
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piotr Laidler / Head of the Biomedical Research Committee of the Jagiellonian University, Biomedical Research Committee of the Jagiellonian University
ClinicalTrials.gov Identifier: NCT01408368     History of Changes
Other Study ID Numbers: BBN/501/ZKL/67/L
Study First Received: August 2, 2011
Last Updated: August 2, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
Graves' disease
total thyroidectomy
bilateral subtotal thyroidectomy
Graves' ophthalmopathy
morbidity rate

Additional relevant MeSH terms:
Graves Disease
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases
Goiter
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on November 25, 2014