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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment

NCT03295864

Arnold-Chiari Malformation, Type 1

COMPLETED NA

Development of a Patient-reported Outcome Measure for Chiari Malformation and Syringomyelia

NCT06011226

Syringomyelia Chiari Malformation

NOT_YET_RECRUITING

Craniosynostosis :Surgical Treatment Modalities and Outcome

NCT05511168

Craniosynostoses

UNKNOWN NA

Clinical Study of the Treatment of Chiari Malformation Combined With Type II Skull Base Depression

NCT05754554

Atlantoaxial Dislocation Chiari Malformation Basilar Invagination

UNKNOWN NA

Postual Control in Pediatric Chiari I Malformation

NCT04679792

Chiari I Malformation Pediatric

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chiari Malformation, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

chiari I malformation patients undergoing craniectomy

modalities and outcomes of surgical treatment of chiari I malformation patients

Group Type EXPERIMENTAL

posterior fossa craniectomy with or without duraplasty

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

posterior 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No