Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis
Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis: An Observational Longitudinal Study
Myasthenia gravis is an autoimmune disorder affecting neuromuscular transmission, characterized by fluctuating muscle weakness and fatigue. Surgical removal of the thymus gland (thymectomy) is an established treatment to help achieve disease control in eligible patients. However, surgery does not guarantee permanent remission, and some individuals experience disease recurrence or clinical worsening.
The main objective of this observational study is to determine the incidence and clinical predictors of early relapse occurring within the first six months following thymectomy. The study evaluates adult patients with confirmed autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. Patient characteristics, antibody profiles, pre-surgical disease severity, and postoperative follow-up assessments at 1, 3, and 6 months will be analyzed to identify factors associated with early clinical relapse.
研究概览
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients diagnosed with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals and have documented clinical follow-up for at least six months post-surgery.
描述
Inclusion Criteria:
- Age 18 years or older at the time of thymectomy
- Definite autoimmune myasthenia gravis based on compatible clinical findings with supporting electrophysiological and/or serological evidence
- History of thymectomy
- Adequate preoperative medical records
- Documented postoperative assessment sufficient to determine six-month outcome, unless a qualifying relapse or death occurs earlier
Exclusion Criteria:
- Congenital myasthenic syndromes
- Insufficient or unreliable medical records
- Absence of reliable postoperative clinical assessment
- Thymectomy performed for an unrelated indication without documented myasthenia gravis
- Major comorbid neurological disease making myasthenia gravis activity assessment unreliable
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
|---|
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Post-Thymectomy Myasthenia Gravis Patients
Adult patients aged 18 years or older with definite autoimmune myasthenia gravis who underwent thymectomy at Assiut University Hospitals. This cohort is evaluated for the incidence, clinical phenotype, and predictors of early clinical relapse occurring within six months post-thymectomy. |
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 |
|---|---|---|
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Number of Participants With Clinically Significant Myasthenia Gravis Relapse
大体时间：6 months post-thymectomy
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Clinically significant relapse is defined as an objective worsening of myasthenia gravis muscle weakness that requires treatment escalation (including increased corticosteroid dosing, addition of non-steroidal immunosuppressive agents, or initiation of rescue therapy with plasma exchange or intravenous immunoglobulin). |
6 months post-thymectomy
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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