The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graves' Ophthalmopathy |
Procedure: Total Thyroidectomy Drug: Propylthiouracil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Improvement in the proptosis and activity of Graves' ophthalmopathy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Total thyroidectomy |
Procedure: Total Thyroidectomy
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
|
| Active Comparator: Anti-thyroid drug |
Drug: Propylthiouracil
150-600 mg in two-three divided doses
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Contact: Özgür Demir, M.D. | 00903125082100 | dr.ozgurdemir@gmail.com |
| Turkey | |
| Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department | Recruiting |
| Ankara, Turkey, 06100 | |
| Contact: Özgür Demir, M.D. 00903125082100 dr.ozgurdemir@gmail.com | |
| Principal Investigator: Özgür Demir, M.D. | |
More Information
No publications provided
| Responsible Party: | Ankara University, Medical School |
| ClinicalTrials.gov Identifier: | NCT01056419 History of Changes |
| Other Study ID Numbers: | 08067 |
| Study First Received: | January 25, 2010 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Turkey: Ethics Committee Turkey: Ministry of Health |
Keywords provided by Ankara University:
|
Graves' ophthalmopathy Total thyroidectomy Anti-thyroid drug treatment Clinical activity score |
Additional relevant MeSH terms:
|
Goiter Eye Diseases Graves Ophthalmopathy Eye Diseases, Hereditary Graves Disease Exophthalmos Orbital Diseases Thyroid Diseases Endocrine System Diseases Hyperthyroidism |
Autoimmune Diseases Immune System Diseases Antithyroid Agents Propylthiouracil Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013