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Subtotal Versus Total Thyroidectomy for Graves' Disease

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01408368
Enrollment
200
Registered
2011-08-03
Start date
2000-01-31
Completion date
2010-12-31
Last updated
2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Goiter, Thyroid

Keywords

Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate

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.

Interventions

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).

PROCEDURETotal thyroidectomy

The intervention consisted of total extracapsular thyroidectomy.

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Long-term control of Graves' diseaseup to 60 months postoperativelyRecurrence rate of hyperthyroidism and change in Graves' ophthalmopathy

Secondary

MeasureTime frameDescription
Morbidity rateup to 12 months postoperativelyrecurrent laryngeal nerve injury and hypoparathyroidism

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026