ClinicalTrials.Veeva

Menu

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

A

Assiut University

Status

Enrolling

Conditions

Chiari Malformation, Type 1

Treatments

Procedure: posterior fossa craniectomy with or without duraplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06029101
Chiari I surgical treatment

Details and patient eligibility

About

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

Full 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).

Enrollment

12 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

chiari I malformation patients undergoing craniectomy
Experimental group
Description:
modalities and outcomes of surgical treatment of chiari I malformation patients
Treatment:
Procedure: posterior fossa craniectomy with or without duraplasty

Trial contacts and locations

1

Loading...

Central trial contact

Ismail Taha, lecturer; Ahmed Hamdy Hussein, demonstrator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems