NCT01056419

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

Status unknown Phase 4 Last updated 25 January 2010

What this trial tests

Phase 4 trial testing Total Thyroidectomy in Graves' Ophthalmopathy in 40 participants. Status unknown.

Timeline

1 January 2009

Primary endpoint
1 June 2010

1 August 2010

Quick facts

Lead sponsor	Ankara University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 January 2009
Primary completion	1 June 2010
Estimated completion	1 August 2010
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Total Thyroidectomy
• Propylthiouracil — full drug profile →

Conditions studied

• Graves' Ophthalmopathy — all drugs for Graves' Ophthalmopathy →

Sponsor

Ankara University

Who can join

Adults 18 to 75, any sex, with Graves' Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Improvement in the proptosis and activity of Graves' ophthalmopathy
  Time frame: 12 months

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A metabolic modeling approach reveals promising therapeutic targets and antiviral drugs to combat COVID-19.
   Santos-Beneit F, Raškevičius V, Skeberdis VA, Bordel S. · · 2021 · cited 33× · PMID 34099831 · DOI 10.1038/s41598-021-91526-3
2. Comparison of Early Total Thyroidectomy with Antithyroid Treatment in Patients with Moderate-Severe Graves' Orbitopathy: A Randomized Prospective Trial.
   Erdoğan MF, Demir Ö, Ersoy RÜ, Gül K, et al · · 2016 · cited 8× · PMID 27493884 · DOI 10.1159/000444796