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Clinical Trials/NCT07381998
NCT07381998Enrolling By InvitationNot Applicable

The Impact of Total Thyroidectomy on Parathyroid Function and Quality of Life

Aarhus University Hospital1 site in 1 country150 target enrollmentStarted: January 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

<75 % fall in intraoperative parathyroidhormone

No Intervention

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

<75 % fall in intraoperative parathyroidhormone experimental

Experimental

Ommit routine blood test on post operative day 1

Intervention: Ommit routine blood test post operative day 1 (Diagnostic Test)

>75% fall in intraoperative parathyroidhormone

No Intervention

Standard treatment

>75% fall in intraoperative parathyroidhormone experimental

Experimental

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

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

Outcomes

Primary Outcomes

Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status

Time Frame: 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)

Time Frame: 1 year

Comparison of plasma ionized calcium (Ca2+ mmol/L) between groups at postoperative day 2 (POD2).

Secondary Outcomes

  • Incidence of clinically significant hypocalcemia requiring medical intervention through 12 months(2 years)
  • Number of postoperative blood tests through 12 months(2 years)
  • Length of index hospital stay after surgery(2 years)
  • Change from baseline in Thyroid-Specific Patient-Reported Outcome measure (ThyPRO-39) score through 12 months(2 years)
  • Change from baseline in 36-Item Short Form Health Survey (SF-36) score through 12 months(2 years)
  • Change from baseline in Hypoparathyroidism Patient Questionnaire (HPQ-27/HPQ-28) score through 12 months(2 years)
  • Adverse events frequency through 12 months(2 years)
  • Incidence of transient hypoparathyroidism through 12 months(2 years)
  • Incidence of permanent hypoparathyroidism at 12 months(2 years)
  • Incidence of postoperative bleeding complication through 30 days(2 years)
  • Incidence of postoperative infection through 30 days(2 years)
  • Incidence of nerve injury through 12 months(2 years)
  • Number of resected parathyroid glands(2 years)
  • Number of lymph nodes removed(2 years)
  • Thyroid pathology findings(2 years)

Investigators

Sponsor
Aarhus University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khalil Rafiqi

Medical Doctor, PhD student

Aarhus University Hospital

Study Sites (1)

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