Subtotal Versus Total Thyroidectomy for Graves' Disease
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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. |
- 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
- 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 |
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| Poland | |
| 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, 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:
|
Goiter Graves Disease Thyroid Diseases Endocrine System Diseases Exophthalmos |
Orbital Diseases Eye Diseases Hyperthyroidism Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013