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

Sponsor

Ankara University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01056419

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graves' Ophthalmopathy	Procedure: Total Thyroidectomy Drug: Propylthiouracil	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2010

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Improvement in the proptosis and activity of Graves' ophthalmopathy [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.