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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Ankara University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01056419
First received: January 25, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Ankara University:

Primary Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056419

Contacts
Contact: Özgür Demir, M.D. 00903125082100 dr.ozgurdemir@gmail.com

Locations
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.         
Sponsors and Collaborators
Ankara University
  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:
Hyperthyroidism
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
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 August 20, 2014