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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01408368 |
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Date of registration:
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02/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Subtotal Versus Total Thyroidectomy for Graves' Disease
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Scientific title:
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Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease. |
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Date of first enrolment:
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January 2000 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01408368 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Marcin Barczynski, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jagiellonian University, Medical College |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- planned thyroid surgery for clinically, biochemically and immunologically diagnosed
Graves' disease in patients with mild active ophthalmopathy and the posterior aspects
of both thyroid lobes appearing normal on ultrasound of the neck.
Exclusion Criteria:
- previous thyroid or parathyroid surgery,
- recurrent hyperthyroidism after radioiodine ablation,
- history of Graves' disease longer than 24 months,
- thyroid nodules within the posterior aspect/s of thyroid lobe/s,
- suspicion of thyroid cancer,
- inactive Graves' ophthalmopathy,
- moderate to severe active Graves' ophthalmopathy,
- preoperative recurrent laryngeal nerve palsy,
- pregnancy or lactation,
- age < 18 years, or > 65 years,
- ASA 4 grade (American Society of Anaesthesiology),
- inability to comply with the follow-up protocol.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thyroid
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Goiter
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Intervention(s)
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Procedure: Bilateral subtotal thyroidectomy
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Procedure: Total thyroidectomy
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Primary Outcome(s)
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Long-term control of Graves' disease
[Time Frame: up to 60 months postoperatively]
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Secondary Outcome(s)
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Morbidity rate
[Time Frame: up to 12 months postoperatively]
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Secondary ID(s)
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BBN/501/ZKL/67/L
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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