Hypoparathyroidism Postprocedural, Quality of Life
Conditions
Brief summary
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
OTHEREmpiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion
OTHERPTH based Calcium Carbonate and Calcitriol repletion
PTH based treatment
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline quality of life at 1 and 4 weeks | Pre-op, 1 week post-op and 4 weeks post-op | Short Form 36 (SF-36) questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol | 1 week post-op, 4 weeks post-op | A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4 |
| Occurence and change in symptoms of hypocalcemia | 1 week post-op, 4 weeks post-op | A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4. |
Countries
Canada
Contacts
Primary ContactJean-Philippe Vezina, MD, FRCSC
Outcome results
None listed