Incidence and Predictors of Early Clinical Relapse Within Six Months After Thymectomy in Patients With Myasthenia Gravis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Congenital myasthenic syndromes
Insufficient or unreliable medical records
Absence of reliable postoperative clinical assessment
Thymectomy performed for an unrelated indication without documented myasthenia gravis
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Post-Thymectomy Myasthenia Gravis Patients
Trial outcomes
Primary outcomes
1
Number of Participants With Clinically Significant Myasthenia Gravis Relapse
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).
Time frame
6 months post-thymectomyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: