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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 (
• Диагностический тест 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

Первичные конечные точки

• Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status [Срок оценки: 2 years]
• Plasma ionized calcium (Ca2+ mmol/L) concentration on postoperative day 2 (POD2) [Срок оценки: 1 year]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Department of Otorhinolaryngology, Head and Neck Surgery — Aarhus

Идентификаторы

NCT: NCT07381998 · 1-10-72-155-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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