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临床试验/NCT07491601
NCT07491601招募中不适用

PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"

Nicolas Schlegel1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2025年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
336
试验地点
1
主要终点
Symptomatic hypoparathyroidism (symptom score) with hypocalcemia

研究概览

简要总结

This study aims to investigate whether an earlier measurement of parathyroid hormone can reduce the number of patients who develop symptomatic hypoparathyroidism. This will provide evidence for a clear algorithm to address this issue after thyroid surgery. It will lead to an improvement in quality of life and a reduction in the distress experienced by affected patients. In addition, it is conceivable that patients' hospital stay could be shortened.

详细描述

Information and Recruitment First, patients who meet the inclusion criteria and do not meet any exclusion criteria will be identified in our surgical-endocrine outpatient clinic. All concomitant medications, particularly any pre-existing vitamin D intake, will be documented. As part of the routine blood sampling, parathyroid hormone, calcium, and vitamin D are determined according to the guidelines in order to detect any pre-existing parathyroid disorders (exclusion criteria). After informing the patient about the indication, necessity, and risks of the planned procedure, an additional explanation is given regarding the possibility of participating in the study.

Both written and oral information about the study will be provided to the patient.

Study Timeline The planned recruitment period is 3 years, followed by a 6-month follow-up. Study Visits After patients are enrolled in the study, baseline characteristics are collected, as well as quality-of-life data using standardized questionnaires (SF-36, STAI-G) and the Health Patient Questionnaire (HPQ28), along with a modified version of the "Hypoparathyroidism Patient Experience Scale - Symptom (HPES)." This questionnaire is included in the appendices and has so far been validated for chronic hypoparathyroidism. Validation for the acute setting is currently being carried out through targeted surveys of our own patient cohort during routine perioperative visits.

Postoperative clinical visits take place on days 0, 1, and 2 in accordance with current clinical standards. In the intervention group, parathyroid hormone is measured directly postoperatively within the first 3 hours after surgery. In the control group, this measurement is performed on the first postoperative day (within 24 hours after surgery) during routine blood sampling. This measurement is also carried out at the same time point-on the first postoperative day-in the intervention group. In both groups, vitamin D and calcium supplementation is initiated if the parathyroid hormone level falls below the normal range. On postoperative days 1 and 2, both groups complete the HPES, HPQ28, and STAI-G questionnaires.

As part of the study, an additional clinical visit and laboratory testing is performed after discharge on days 8-10. This additional visit is normally conducted only in patients who showed abnormalities during their hospital stay, such as low calcium or parathyroid hormone levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Age ≥ 18 years
  • Thyroidectomy or bilateral thyroid resection of any indication
  • Written informed consent obtained after detailed patient information and provision of an information sheet

排除标准

  • Age ≤ 18 years
  • Concomitant parathyroid disease (primary or secondary hyperparathyroidism, pre-existing hypoparathyroidism of any cause)
  • Previous surgery in the neck region
  • Pregnancy or breastfeeding
  • Inability to attend study visits
  • Participation in another study that interferes with the endpoints
  • Missing or inadequate patient information

结局指标

主要结局

Symptomatic hypoparathyroidism (symptom score) with hypocalcemia

时间窗: within hospital stay (0-48hours after bilateral thyroid surgery)

Symptomatic hypoparathyroidism is defined as the presence of one or more symptoms reported in the questionnaire.

次要结局

  • Length of Hospital stay(up to 14 days after surgery, on average 2 days)
  • Initation of substitution therapy with active vitamin D and calcium(up to 6 months after surgery)
  • Quality of life with changes in psychological burden(up to 1 day before surgery or earlier and after 6 months after surgery)
  • Patient readmission due to hypocalcemia with or without symptoms(up to 6 months after surgery)

研究者

发起方
Nicolas Schlegel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicolas Schlegel

Prof. Dr. med. Nicolas Schlegel

University of Wuerzburg

研究点 (1)

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