Health TrialsbyHealthPanel

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

ConditionsHypoparathyroidism PostproceduralQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCHU de Quebec-Universite Laval

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Total thyroidectomy or completion hemithyroidectomy

Disqualifiers

Need for neck dissection

Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empiric use of Calcium Carbonate and Calcitriol

    Other intervention

    Empiric calcium carbonate and calcitriol repletion

  • PTH based Calcium Carbonate and Calcitriol repletion

    Other intervention

    PTH based treatment

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Empiric calcium and calcitriol repletion groupExperimental treatment 1 intervention
Group B: PTH based repletion groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline quality of life at 1 and 4 weeks

Short Form 36 (SF-36) questionnaire

Time frame
Pre-op, 1 week post-op and 4 weeks post-op

Secondary outcomes

1

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

Time frame
1 week post-op, 4 weeks post-op
2

Occurence and change in symptoms of hypocalcemia

A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.

Time frame
1 week post-op, 4 weeks post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHU de Quebec-Universite Laval

Lead sponsor

Source ClinicalTrials.gov
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