Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029101
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-25
Brief Title:
Modalities of Surgical Treatment of Chiari Malformation Disease Clinical Study and Outcomes
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Modalities of Surgical Treatment of Chiari Malformation Disease Clinical Study and Outcomes
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital
Detailed Description:
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 andor death
The outcome will be measured by reduction increase of symptoms and signs using the Chicago Chiari outcome scale CCOS
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 andor death
The outcome will be measured by reduction increase of symptoms and signs using the Chicago Chiari outcome scale CCOS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None