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

Not Applicable

Recruiting

• Conditions: Hypoparathyroidism Postprocedural; Quality of Life
• Interventions: Other: Empiric use of Calcium Carbonate and Calcitriol; Other: PTH based Calcium Carbonate and Calcitriol repletion

• Registration Number: NCT03249012
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Study Start: 2017-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empiric calcium and calcitriol repletion group	Empiric use of Calcium Carbonate and Calcitriol	All patients in this group will receive post-operative calcium carbonate and calcitriol.
PTH based repletion group	PTH based Calcium Carbonate and Calcitriol repletion	Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de Quebec; 🇨🇦 Québec, Quebec, Canada