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
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Goiter||Procedure: Bilateral subtotal thyroidectomy Procedure: Total thyroidectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|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
- Long-term control of Graves' disease [ Time Frame: up to 60 months postoperatively ]Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy
- Morbidity rate [ Time Frame: up to 12 months postoperatively ]recurrent laryngeal nerve injury and hypoparathyroidism
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
|Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery|
|Krakow, Poland, 31-202|
|Principal Investigator:||Marcin Barczynski, MD, PhD||Jagiellonian University|