Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes

Study Overview
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Brief Summary
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Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital .

Detailed Description
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Chiari malformation is a group of craniocervical malformations involving the brain stem, cerebellum, upper spinal cord, and surrounding bony structure, encompassing a series of hindbrain herniation symptoms. The Austrian pathologist Hans Chiari ﬁrst described the malformation in 1891 and such abnormality is frequently identiﬁed in both young adult and pediatric patients. There are four main types of chiari malformations with other subtypes. Chiari I malformation (CIM), in which the caudal poles of the cerebellar tonsils extend into the upper cervical spinal canal, is a common clinical type. Common clinical symptoms, including headache, altered sensation, weakness, dysphagia, sleep apnea. Between 70% and 80% of patients with CIM have accompanying syringomyelia. Surgical treatment is widely accepted and is the only treatment chosen for symptomatic patients with Chiari malformations. The aim of this study is to elucidate the most favorable procedures for CIM in terms of radiological and clinical outcomes. Independent and dependent variables will be identiﬁed for analysis. The independent variables will include patient diagnosis, surgical techniques, patient age, patient chronic diseases and identified dependent variables including improvement of symptoms and signs, rates of intraoperative and postoperative adverse events, and perioperative mortality. Different surgical modalities will be applied ,examples include bony decompression with or without duraplasty with the possibility of cerebellar tonsils resection (RT) . Common complications include meningitis, CSF leak, pseudomeningocele, hydrocephalus, respiratory failure, hemorrhage, craniocervical instability, and/or death. The outcome will be measured by reduction / increase of symptoms and signs using the Chicago Chiari outcome scale (CCOS).

Official Title
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Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes

Conditions
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Chiari Malformation, Type 1

Intervention / Treatment
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* Procedure: posterior fossa craniectomy with or without duraplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations. Patients fit for surgery Exclusion Criteria: Other types of Chiari malformations Patients with multilevel cervical disc herniation . Patients with segmental instability . Patients unfit for surgery

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chiari I malformation patients undergoing craniectomy<br>modalities and outcomes of surgical treatment of chiari I malformation patients | Procedure: posterior fossa craniectomy with or without duraplasty<br>* craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital . | using chicago chiari outcome score The Chicago Chiari Outcome Scale (CCOS) uses 4 postoperative outcome categories (pain, nonpain symptoms, functionality, and complications) graded 1 to 4 for a total possible score of 16 , when the score is higher ,it means better outcome. pain for example will be measured by Visual Analog Score for pain. | 4 weeks postoperative |