Behandeling met radioactief jodium versus hemithyreoïdectomie, welke behandeling heeft het beste effect heeft op klachten bij patiënten met symptomatisch euthyreoot struma
- Conditions
- benign euthyroid goitrestruma
- Registration Number
- NL-OMON29617
- Lead Sponsor
- - AMC <br>- Flevoziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Patients with symptomatic goitre
- Goitre size larger than 40 ml on one side determined on CT
Exclusion Criteria
- Goitre suspicious of malignancy on imaging
- Bethesda 5 or 6 cytology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduction of symptoms 12 months after treatment measured with ThyPro Questionnaire
- Secondary Outcome Measures
Name Time Method - Quality of life measured by EQ-5D-5L questionnaire after 6 months and 1-5 years <br /><br>- Voice impairment after 6 months and 1-5 years as measured by the Voice Handicap<br>Index, a specific questionnaire for voice impairment detection a <br /><br>- Effect of treatment on symptoms after 6 months, 2, 3, 4 and 5 years after treatment<br>as measurd by the ThyPRO questionnairre <br /><br>- Goitre volume as measured on a CT-scan 12 months after treatment <br /><br>- Serum TSH, T4 levels, PTH (standard 2-6 weeks after treatment or if measured under<br>routine care at any time during follow-up) <br /><br>- Hypo- or hyperthyroidism <br /><br>- Peri-operative complications: vocal cords palsy <br /><br>- Complications of radioactive iodine