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临床试验/NCT04648722
NCT04648722已完成不适用

Higher Post-operative Levothyroxine Substitution Dose Needed in Right Compared to Left Lobe Hemithyroidectomy - a Retrospective Cohort Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
459
试验地点
1
主要终点
Levothyroxine dosage

研究概览

简要总结

459 adult patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018 were identified and investigated in this retrospective study. The aim of this study was to investigate whether patients post right side hemithyroidectomy require a higher mean levothyroxine dosage than patients after left lobe hemithyroidectomy as the right thyroid lobe is bigger than the left lobe. Further, we aimed at developing a better post-surgery thyroid dosage prediction model.

详细描述

In most patients, the right lobe of the thyroid gland is larger than the left lobe. After a hemithyroidectomy, the remaining lobe grows by up to 30% to compensate for the loss. However, thyroxine replacement is still necessary for 22% to 60% of all patients. The aim of this study is to investigate whether a right-lobe hemithyroidectomy predisposes to a higher postoperative dose of levothyroxine.

Patients and Methods In a retrospective cohort study, 459 patients over the age of 18 years who underwent a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up (3-12 months post-surgery) visit at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism between 1994 and 2018 were investigated. The study was approved by the local ethics committee and performed in accordance with the Declaration of Helsinki. The work has been reported in line with the STROCSS criteria. The patients were identified via data extraction from a university hospital-wide Research, Documentation and Analysis (RDA) database. In a second step, further information necessary for the analysis (ultrasound data on pre-surgery thyroid volume, pre-surgery TSH, side and date of hemithyroidectomy, surgery protocol, underlying thyroid disease, type and dosage of treatment, age, weight, height, thyrotropin (TSH), free T4 (fT4), free T3 (fT3)) were extracted from the internal electronic health record system. Patients who had either received radiation therapy had undergone previous thyroid surgery, surgery on the contralateral lobe, had pre-existing hypothyroidism, an autoimmune disease of the thyroid or were pregnant were excluded from the analysis. 33 patients were excluded due to additional surgery on the contralateral lobe resulting in a total of 426 patients. Pre-surgery ultrasound thyroid volume was calculated with the volumetric ellipsoid method (height × width × depth × correction factor 0.524).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Males and females
  • St.p. hemithyroidectomy

排除标准

  • Radiation therapy
  • Pregnancy
  • Previous thyroid surgery (e.g. nodule removal surgery)

结局指标

主要结局

Levothyroxine dosage

时间窗: within 3 to 12 months post surgery

dosage of levothyroxine needed post surgery, compared between left and right side hemithyroidectomy

次要结局

  • Hypothyroidism(within 3 to 12 months post surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carola Deischinger

Principal investigator

Medical University of Vienna

研究点 (1)

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