Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empiric use of Calcium Carbonate and Calcitriol, PTH based Calcium Carbonate and Calcitriol repletion.
- Who it may be relevant to
- Registry conditions: Hypoparathyroidism Postprocedural, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
Overview
This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.
Detailed description
Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15.
The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.
Interventions
- Other Empiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion - Other PTH based Calcium Carbonate and Calcitriol repletion
PTH based treatment
Primary outcome measures
- Change from baseline quality of life at 1 and 4 weeks [Time frame: Pre-op, 1 week post-op and 4 weeks post-op]
Secondary outcome measures (2)
- Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol [Time frame: 1 week post-op, 4 weeks post-op]
- Occurence and change in symptoms of hypocalcemia [Time frame: 1 week post-op, 4 weeks post-op]
Eligibility criteria
Inclusion criteria
- Total thyroidectomy or completion hemithyroidectomy
Exclusion criteria
- Need for neck dissection
- Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- CHU de Quebec — Québec
Identifiers
NCT: NCT03249012 · 2018-3422