External validation of a risk stratification predicting hypothyroidism after hemithyroidectomy (INFORM-2-trial)

External validation of a risk stratification predicting hypothyroidism after hemithyroidectomy (INFORM-2-trial) - INFORM-2-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57697

Enrollment

500

Registered

2017-07-21

Start date

2017-10-02

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Hypothyroidims low thyroid hormone levels

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Planned hemithyroidectomy 2. Age 18 years or older

Exclusion criteria

Exclusion criteria: 1. Thyroid dysfunction preoperatively ((sub-)clinical hypo- or hyperthyroidism) 2. Previous thyroid surgery 3. History of external beam irradiation on the neck 4. Pregnancy 5. Unable to give informed consent 6. Completion thyreoidectomy

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is the correlation between the actual risk for thyroxine supplementation and the predicted risk of thyroxine supplementation, according to the risk stratification of Lee et al.	—

Secondary

Measure	Time frame
Secondary study endpoints consist of the incidence of hypothyroidism and risk factors for hypothyroidism.	—

Countries

Netherlands

Outcome results