The Impact of Total Thyroidectomy on Parathyroid Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) undergoing Total thyroidectomy with intraoperative PTH measurements.
排除标准
- •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.
研究组 & 干预措施
<75 % fall in intraoperative parathyroidhormone
Standard blood test on post operative day 1 including PTH and P-ca
<75 % fall in intraoperative parathyroidhormone experimental
Ommit routine blood test on post operative day 1
干预措施: Ommit routine blood test post operative day 1 (Diagnostic Test)
>75% fall in intraoperative parathyroidhormone
Standard treatment
>75% fall in intraoperative parathyroidhormone experimental
Start in Unikalk 4 times per day + d-vitamin + alfacalcidol 2 microgram 2 times per day.
干预措施: high-dose calcium (400 mg x 4), vitamin D (19 mikg x 4), and active vitamin D supplementation (2 mikg x 2) (Drug)
结局指标
主要结局
Plasma ionized calcium (Ca2+) concentration at postoperative week 1 (POD7), by POD1 biochemical testing status
时间窗: 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)
时间窗: 1 year
Comparison of plasma ionized calcium (Ca2+ mmol/L) between groups at postoperative day 2 (POD2).
次要结局
- 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)
研究者
Khalil Rafiqi
Medical Doctor, PhD student
Aarhus University Hospital