Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life
Enrolling by invitation · Not applicable
Conditions studied: Hypoparathyroidism Post-surgical, Quality of Life
In brief
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.
Key facts
- Study ID
- NCT07381998
- Run by
- Aarhus University Hospital
- People needed
- 150
- Starts
- 2026-01-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.
You may not qualify if…
- 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.
Where it is running
- Department of Otorhinolaryngology, Head and Neck Surgery — Aarhus, Central Jutland, Denmark
Full record on ClinicalTrials.gov
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