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Subtotal Versus Total Thyroidectomy for Graves' Disease

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ClinicalTrials.gov Identifier: NCT01408368
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
Sponsor:
Information provided by:
Jagiellonian University

Brief Summary:
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 or disease Intervention/treatment Phase
Thyroid Goiter Procedure: Bilateral subtotal thyroidectomy Procedure: Total thyroidectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : January 2000
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Long-term control of Graves' disease [ Time Frame: up to 60 months postoperatively ]
    Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy


Secondary Outcome Measures :
  1. Morbidity rate [ Time Frame: up to 12 months postoperatively ]
    recurrent laryngeal nerve injury and hypoparathyroidism



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408368


Locations
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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
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Principal Investigator: Marcin Barczynski, MD, PhD Jagiellonian University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    
Other Study ID Numbers: BBN/501/ZKL/67/L
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011
Keywords provided by Jagiellonian University:
Graves' disease
total thyroidectomy
bilateral subtotal thyroidectomy
Graves' ophthalmopathy
morbidity rate
Additional relevant MeSH terms:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases