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

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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46798
Enrollment
70
Registered
2018-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Struma zwelling schildklier

Interventions

Radioactive iodine treatment conform local treatment protocols or hemithyroidectomy with resection of the largest lobe.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary outcome is the reduction of symptoms 12 months after treatment, as measured by a decrease of complaints on self-reported QoL questionnaire (THYRPRO).

Secondary

MeasureTime frame
Secondary outcomes are goiter volume as measured on a CT-scan without contrast 1 year after treatment and complications (vocal cords palsy, hypo- or hyperthyroidism.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)