Radioactive iodine treatment versus hemithyroidectomy in patients with symptomatic benign euthyroid goitre

Phase 4

Withdrawn

• Conditions: Struma; zwelling schildklier; 10043739; 10014705

• Registration Number: NL-OMON46798
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Patients with symptomatic goitre
- Goitre size larger than 40 ml on one side determined on CT
- Patients accept both treatment modalities
- TSH between 0,5-5,0 mE/L (euthyroidism) without Thyroid suppletion
- Not pregnant or childwish within 64 months after treatment
- Able to undergo surgery as well as radioiodine treatment (hoe te definieren)
- Able to fill in questionnaires and give Informed Consent
- 18 years or older

Exclusion Criteria

- Goitre suspicious of malignancy on imaging
- Bethesda 5 or 6 cytology
- Hyperthyroidism
- Previous history of thyroid surgery or radioactive iodine
- Not eligible for general anesthesia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the reduction of symptoms 12 months after treatment, as<br /><br>measured by a decrease of complaints on self-reported QoL questionnaire<br /><br>(THYRPRO). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are goiter volume as measured on a CT-scan without contrast<br /><br>1 year after treatment and complications (vocal cords palsy, hypo- or<br /><br>hyperthyroidism. </p><br>