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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06029101
Enrollment
12
Registered
2023-09-08
Start date
2023-04-01
Completion date
2024-09-30
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chiari Malformation, Type 1

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, and/or death. The outcome will be measured by reduction / increase of symptoms and signs using the Chicago Chiari outcome scale (CCOS).

Interventions

PROCEDUREposterior fossa craniectomy with or without duraplasty

craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .4 weeks postoperativeusing 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.

Countries

Egypt

Contacts

Primary ContactAhmed Hamdy Hussein, demonstrator
ahmedhamdyhussein@med.nvu.edu.eg01103960297 - 01020836040
Backup ContactIsmail Taha, lecturer
01006268779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026