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

NCT ID: NCT03249012

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Hypoparathyroidism Postprocedural Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Empiric calcium and calcitriol repletion group

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

Group Type EXPERIMENTAL

Empiric use of Calcium Carbonate and Calcitriol

Intervention Type OTHER

Empiric calcium carbonate and calcitriol repletion

PTH based repletion group

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

Group Type EXPERIMENTAL

PTH based Calcium Carbonate and Calcitriol repletion

Intervention Type OTHER

PTH based treatment

Interventions

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Empiric use of Calcium Carbonate and Calcitriol

Empiric calcium carbonate and calcitriol repletion

Intervention Type OTHER

PTH based Calcium Carbonate and Calcitriol repletion

PTH based treatment

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Jean-Philippe Vézina

Otolaryngologist and Head & Neck Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU de Quebec

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jean-Philippe Vezina, MD, FRCSC

Role: CONTACT

418-649-0252

Facility Contacts

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Jean-Philippe Vezina, MD

Role: primary

418-649-0252

Other Identifiers

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2018-3422

Identifier Type: -

Identifier Source: org_study_id

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