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

Graves' Ophthalmopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01056419
• Other study ID #: 08067
• Status: Recruiting
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: January 25, 2010
• Start date: January 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2009
• Source: Ankara University
• Contact: Özgür Demir, M.D.
• Phone: 00903125082100
• Email: dr.ozgurdemir[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Graves' Ophthalmopathy

Intervention

Procedure:
• Total Thyroidectomy
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy

Drug:
• Propylthiouracil
150-600 mg in two-three divided doses

Locations

Country	Name	City	State
Turkey	Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the proptosis and activity of Graves' ophthalmopathy		12 months	No