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

Not Applicable

Recruiting

• Conditions: Hypoparathyroidism Postprocedural; Quality of Life

• 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

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