The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
Primary Purpose
Graves' Ophthalmopathy
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Total Thyroidectomy
Propylthiouracil
Sponsored by
About this trial
This is an interventional treatment trial for Graves' Ophthalmopathy focused on measuring Graves' ophthalmopathy, Total thyroidectomy, Anti-thyroid drug treatment, Clinical activity score
Eligibility Criteria
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)
Sites / Locations
- Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Total thyroidectomy
Anti-thyroid drug
Arm Description
Outcomes
Primary Outcome Measures
Improvement in the proptosis and activity of Graves' ophthalmopathy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01056419
Brief Title
The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ankara University
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Ophthalmopathy
Keywords
Graves' ophthalmopathy, Total thyroidectomy, Anti-thyroid drug treatment, Clinical activity score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total thyroidectomy
Arm Type
Active Comparator
Arm Title
Anti-thyroid drug
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Total Thyroidectomy
Intervention Description
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
Intervention Type
Drug
Intervention Name(s)
Propylthiouracil
Intervention Description
150-600 mg in two-three divided doses
Primary Outcome Measure Information:
Title
Improvement in the proptosis and activity of Graves' ophthalmopathy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özgür Demir, M.D.
Phone
00903125082100
Email
dr.ozgurdemir@gmail.com
Facility Information:
Facility Name
Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özgür Demir, M.D.
Phone
00903125082100
Email
dr.ozgurdemir@gmail.com
First Name & Middle Initial & Last Name & Degree
Özgür Demir, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy
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