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

Aarhus University Hospital

Status: Invitation-only

Conditions: Quality of Life; Hypoparathyroidism Post-surgical

Treatments: Drug: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2); Diagnostic Test: Ommit routine blood test post operative day 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07381998

1-10-72-155-25

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

<75 % fall in intraoperative parathyroidhormone

No Intervention group

Description:

Standard blood test on post operative day 1 including PTH and P-ca

<75 % fall in intraoperative parathyroidhormone experimental

Experimental group

Description:

Ommit routine blood test on post operative day 1

Treatment:

Diagnostic Test: Ommit routine blood test post operative day 1

>75% fall in intraoperative parathyroidhormone

No Intervention group

Description:

Standard treatment

>75% fall in intraoperative parathyroidhormone experimental

Experimental group

Description:

Start in Unikalk 4 times per day + d-vitamin + alfacalcidol 2 microgram 2 times per day.

Treatment:

Drug: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2)