The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
NCT ID: NCT01056419
Last Updated: 2010-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2009-01-31
2010-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total thyroidectomy
Total Thyroidectomy
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
Anti-thyroid drug
Propylthiouracil
150-600 mg in two-three divided doses
Interventions
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Total Thyroidectomy
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
Propylthiouracil
150-600 mg in two-three divided doses
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Ankara University, Medical School
Locations
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Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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08067
Identifier Type: -
Identifier Source: org_study_id
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