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

Phase 4

• Conditions: Graves' Ophthalmopathy
• Interventions: Procedure: Total Thyroidectomy; Drug: Propylthiouracil

• Registration Number: NCT01056419
• Lead Sponsor: Ankara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Last Update Submitted: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Posted: 2010-01-26
• Primary Completion: 2010-06
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total thyroidectomy	Total Thyroidectomy	-
Anti-thyroid drug	Propylthiouracil	-

Primary Outcome Measures

Name	Time	Method
Improvement in the proptosis and activity of Graves' ophthalmopathy	12 months

Trial Locations

Locations (1)

Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department; 🇹🇷 Ankara, Turkey