About this trial
This study aims to investigate whether an earlier measurement of parathyroid hormone can reduce the number of patients who develop symptomatic hypoparathyroidism. This will provide evidence for a clear algorithm to address this issue after thyroid surgery. It will lead to an improvement in quality of life and a reduction in the distress experienced by affected patients. In addition, it is conceivable that patients' hospital stay could be shortened.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Thyroidectomy or bilateral thyroid resection of any indication
Written informed consent obtained after detailed patient information and provision of an information sheet
Disqualifiers
Age ≤ 18 years
Concomitant parathyroid disease (primary or secondary hyperparathyroidism, pre-existing hypoparathyroidism of any cause)
Previous surgery in the neck region
Pregnancy or breastfeeding
Trial design
Crossover
Treatments tested in this trial
Active vitamin D
DrugApplication if parathyroid hormone level falls below normal
Calcium
DrugAdministered if parathyroid hormone level falls below normal
Treatment groups
Trial outcomes
Primary outcomes
Symptomatic hypoparathyroidism (symptom score) with hypocalcemia
Symptomatic hypoparathyroidism is defined as the presence of one or more symptoms reported in the questionnaire.
Secondary outcomes
Length of Hospital stay
Duration of hospital stay
Initation of substitution therapy with active vitamin D and calcium
Duration of supplementation based on symtptoms and biochemical restoration of PTH levels
Quality of life with changes in psychological burden
Measurement of Quality of Life using Short Form (36) Healthy Survey (SF36), State-Trait Anxiety Inventory- German version (STAI-G) and Hypoparathyroidism Patient Questionnaire 28 (HPQ28)
Patient readmission due to hypocalcemia with or without symptoms
Patients with problems after discharge who require readmission
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicolas Schlegel
Lead sponsor
University of Wuerzburg
Sponsor institution
University of Wuerzburg
Collaborator