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Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma

2026年9月17日 更新者:Serkan Karaisli、Izmir Katip Celebi University

Aim: Intraoperative neuromonitoring (IONM) is frequently used in cases of primary hyperparathyroidism (pHPT); however, its role in cases of solitary parathyroid adenoma has not been clearly defined, and differing opinions exist on the matter. This study aimed to evaluate the impact of IONM on surgical outcomes in patients undergoing parathyroidectomy for solitary parathyroid adenoma.

Methods: Patients with localized solitary parathyroid adenoma were operated on by experienced endocrine surgeons at our clinic. Patients undergoing four-gland exploration or unilateral exploration, as well as those with a history of neck surgery and/or radiotherapy, were excluded from the study. Patient data were analyzed prospectively. Patients were divided into two groups: those who underwent IONM and those who did not. Demographic characteristics, preoperative and intraoperative data, and postoperative follow-up results were compared between the groups. The IONM procedure was performed in accordance with international IONM standards. Patients were randomized prior to surgery by a resident physician using a method where they drew a card from a bag.

研究概览

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • İzmir
      • Izmir、İzmir、土耳其(türkiye)、35100
        • Izmir Katip Celebi University Ataturk Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Being 18 years of age or older,
  • The adenoma being localized to the same location on both ultrasound and scintigraphy
  • No history of neck intervention for any reason,
  • No planned concurrent thyroid surgery or four-gland exploration,
  • Normal preoperative vocal cord assessment.

Exclusion Criteria:

  • Being under the age of 18,
  • Having undergone thyroid and parathyroid surgery,
  • Cases known to be familial preoperatively,
  • Cases scheduled for four-gland exploration,
  • Cases with a history of neck radiotherapy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:IONM GROUP

Patients undergoing parathyroid surgery with intraoperative neuromonitoring.

INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION.

无干预:NON-IONM GROUP

Patients undergoing parathyroid surgery without intraoperative neuromonitoring.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
大体时间:Postoperative Day 1 and 1 Week After Surgery

Postoperative vocal cord function will be assessed by laryngoscopic examination and reported as the number and percentage of patients with normal or abnormal vocal cord function

Postoperative Day 1 and 1 Week After Surgery

次要结果测量

结果测量
措施说明
大体时间
Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
大体时间:10th minute after parathyroidectomy

Surgical success will be assessed according to the Miami criterion, defined as a ≥50% decrease in intraoperative parathyroid hormone (IOPTH) level from the highest pre-excision or baseline value to the 10-minute post-excision measurement. The outcome will be reported as the number and percentage of patients meeting the Miami criterion.

10th minute after parathyroidectomy
Operative Time, Reported in Minutes
大体时间:During surgery

Operative time will be measured from the beginning of the surgical incision to completion of skin closure and will be reported in minutes.

During surgery
Incision Length, Reported in Millimeters
大体时间:At the end of surgery

The length of the surgical incision will be measured at the end of the surgical procedure and reported in millimeters.

At the end of surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:MEHMET HACIYANLI, MD、Izmir Katip Celebi University Ataturk Training and Research Hospital
  • 首席研究员:MERT YOLDAŞ、Izmir Katip Celebi University Ataturk Training and Research Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年2月21日

初级完成 (实际的)

2025年12月31日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2026年9月14日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月23日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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