Subtotal Versus Total Thyroidectomy for Graves' Disease

Study Overview
=================
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.

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.

Official Title
-----------------
Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.

Conditions
-----------------
Thyroid, Goiter

Intervention / Treatment
-----------------
* Procedure: Bilateral subtotal thyroidectomy
* Procedure: Total thyroidectomy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral subtotal thyroidectomy<br> | Procedure: Bilateral subtotal thyroidectomy<br>* 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).<br>* Other names: BST;|
| Experimental: Total thyroidectomy<br> | Procedure: Total thyroidectomy<br>* The intervention consisted of total extracapsular thyroidectomy.<br>* Other names: TT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term control of Graves' disease | Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy | up to 60 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate | recurrent laryngeal nerve injury and hypoparathyroidism | up to 12 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate