Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism

Conditions
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Hypoparathyroidism Postprocedural, Quality of Life

Intervention / Treatment
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* Other: Empiric use of Calcium Carbonate and Calcitriol
* Other: PTH based Calcium Carbonate and Calcitriol repletion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empiric calcium and calcitriol repletion group<br>All patients in this group will receive post-operative calcium carbonate and calcitriol. | Other: Empiric use of Calcium Carbonate and Calcitriol<br>* Empiric calcium carbonate and calcitriol repletion<br>|
| Experimental: PTH based repletion group<br>Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH. | Other: PTH based Calcium Carbonate and Calcitriol repletion<br>* PTH based treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline quality of life at 1 and 4 weeks | Short Form 36 (SF-36) questionnaire | Pre-op, 1 week post-op and 4 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol | A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4 | 1 week post-op, 4 weeks post-op | 
| Occurence and change in symptoms of hypocalcemia | A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4. | 1 week post-op, 4 weeks post-op |