Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life

Condition(s) studied

Investigational drug(s) / intervention(s)

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 (\<1.0 pmol/L) and low Ca2+ (\<1.10 mmol/L).

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status — 2 years
  Comparison of plasma ionized calcium (Ca2+ mmol/L) and parathyroid hormone (PTH pmol/L) after one postoperative week between patients with and without biochemical measurements at post operative day 1 (POD1.)
• Plasma ionized calcium (Ca2+ mmol/L) concentration on postoperative day 2 (POD2) — 1 year
  Comparison of plasma ionized calcium (Ca2+ mmol/L) between groups at postoperative day 2 (POD2).

Trial sites (1)

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