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

Laval University

Status: Enrolling

Conditions: Hypoparathyroidism Postprocedural; Quality of Life

Treatments: Other: PTH based Calcium Carbonate and Calcitriol repletion; Other: Empiric use of Calcium Carbonate and Calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT03249012

2018-3422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Empiric calcium and calcitriol repletion group

Experimental group

Description:

All patients in this group will receive post-operative calcium carbonate and calcitriol.

Treatment:

Other: Empiric use of Calcium Carbonate and Calcitriol

PTH based repletion group

Experimental group

Description:

Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Treatment:

Other: PTH based Calcium Carbonate and Calcitriol repletion