Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2), Ommit routine blood test post operative day 1.
- Who it may be relevant to
- Registry conditions: Hypoparathyroidism Post-surgical, Quality of Life. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Total Thyroidectomy on Parathyroid Function and Quality of Life
Overview
Postoperative hypoparathyroidism (hypoPT) is the most frequent complication after total thyroidectomy (TT). It is caused by impaired parathyroid function, leading to low calcium levels, patient discomfort, reduced quality of life (QoL), and increased healthcare costs. Traditionally, all TT patients undergo routine postoperative blood testing and standard calcium supplementation, despite varying individual risk. This investigator-initiated project aims to improve patient outcomes by using intraoperative parathyroid hormone (ioPTH) measurements to guide postoperative care. The ioPTH decline reflect parathyroid function immediately after surgery and can identify patients at high or low risk of hypoPT. The study is designed as a prospective, randomized controlled trial (RCT) with two arms: Arm A (\<75% ioPTH decrease): Patients randomized to either omission of routine postoperative calcium/PTH blood tests or standard monitoring. Arm B (\>75% ioPTH decrease): Patients randomized to either early high-dose calcium and vitamin D supplementation or standard therapy. Primary outcomes are calcium and PTH levels postoperatively, incidence of hypocalcemia, and healthcare resource use. Secondary outcomes include QoL assessed by validated questionnaires (ThyPro39, SF-36, HPQ27), transient and permanent hypoPT rates, and other surgical complications. By tailoring care to individual risk, the study aims to safely reduce unnecessary blood tests and optimize early treatment for high-risk patients. This approach has the potential to shorten hospital stays, reduce symptoms, improve QoL, and lower costs. The findings may influence clinical guidelines nationally and internationally, supporting more personalized and evidence-based management of TT patients.
Interventions
- Drug high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2)
Standard postoperative treatment includes low-dose calcium (400 mg x 2) and vitamin D (19 mikg x 2) is initiated for all patients. In the intervention group, patients are randomized to standard low-dose (control group) or standard high-dose treatment including immediate postoperative initiation of high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2). In the control group, treatment with active vitamin D is only initiated in case of low PTH ( - Diagnostic test Ommit routine blood test post operative day 1
Patients are randomized to either clinical monitoring only, without routine postoperative POD1 measurements of Ca2+ and PTH in one group or standard postoperative care, including routine blood tests for Ca2+ and PTH at POD1. All patients will have Ca2+ and PTH measured after the first postoperative week
Primary outcome measures
- Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status [Time frame: 2 years]
- Plasma ionized calcium (Ca2+ mmol/L) concentration on postoperative day 2 (POD2) [Time frame: 1 year]
Secondary outcome measures (12)
- Incidence of clinically significant hypocalcemia requiring medical intervention through 12 months [Time frame: 2 years]
- Number of postoperative blood tests through 12 months [Time frame: 2 years]
- Length of index hospital stay after surgery [Time frame: 2 years]
- Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score through 12 months [Time frame: 2 years]
- Change from baseline in 36-Item Short Form Health Survey (SF-36) score through 12 months [Time frame: 2 years]
- Change from baseline in Hypoparathyroidism Patient Questionnaire (HPQ-27/HPQ-28) score through 12 months [Time frame: 2 years]
- Adverse events frequency through 12 months [Time frame: 2 years]
- Incidence of transient hypoparathyroidism through 12 months [Time frame: 2 years]
- Incidence of permanent hypoparathyroidism at 12 months [Time frame: 2 years]
- Incidence of postoperative bleeding complication through 30 days [Time frame: 2 years]
- Incidence of postoperative infection through 30 days [Time frame: 2 years]
- Incidence of nerve injury through 12 months [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.
Exclusion criteria
- Malabsorption (intestinal resection or gastric by-pass).
- Renal insufficiency (eGFR<30 ml/min) or deemed clinically high-risk requiring mandatory biochemical monitoring.
- Hypercalcemia (Ca2+ > 1.32 mmol/L).
- Previous thyroid or parathyroid operations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of Otorhinolaryngology, Head and Neck Surgery — Aarhus
Identifiers
NCT: NCT07381998 · 1-10-72-155-25