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The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01056419
Enrollment
40
Registered
2010-01-26
Start date
2009-01-31
Completion date
2010-08-31
Last updated
2010-01-26

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

Conditions

Graves' Ophthalmopathy

Keywords

Graves' ophthalmopathy, Total thyroidectomy, Anti-thyroid drug treatment, Clinical activity score

Brief summary

The relationship between the method of the treatment of hyperthyroidism due to Graves' disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to compare the results of total thyroidectomy done in 6 months following the appearance of the symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to severe Graves' ophthalmopathy. The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography, 3)Patients taking no treatment except local medications for Graves' ophthalmopathy, 4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm. All patients will be treated with antithyroid drug until TSH levels of the patients are between 0.4-1. During this period all the patients will take pulse methyl prednisolone treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be randomised to two groups: one group will be sent to surgery for total thyroidectomy, and their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group will be followed under antithyroid drug treatment and their TSH levels will be kept between 0.4-1 also. The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months intervals for a period of 12 months.

Interventions

PROCEDURETotal Thyroidectomy

Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy

150-600 mg in two-three divided doses

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months, * Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography, * Patients taking no treatment except local medications for Graves' ophthalmopathy, * Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm.

Exclusion criteria

* Patients taking treatment other than local medications for Graves' ophthalmopathy (eg: steroid treatment)

Design outcomes

Primary

MeasureTime frame
Improvement in the proptosis and activity of Graves' ophthalmopathy12 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzgür Demir, M.D.
dr.ozgurdemir@gmail.com00903125082100

Outcome results

None listed

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