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

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

Study Overview

• Status: Recruiting
• Conditions: Chiari Malformation, Type 1
• Intervention / Treatment: Procedure: posterior fossa craniectomy with or without duraplasty

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).

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Hamdy Hussein, demonstrator; Phone Number: 01103960297 - 01020836040; Email: ahmedhamdyhussein@med.nvu.edu.eg
• Study Contact Backup: Name: Ismail Taha, lecturer; Phone Number: 01006268779

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chiari I malformation patients undergoing craniectomy; modalities and outcomes of surgical treatment of chiari I malformation patients	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohamed Taghian, professor, Assiut University; Study Director: Ahmed Abdallah, Ass. prof, Assiut University; Study Director: Ismail Taha, lecturer, Assiut University

Publications and helpful links

General Publications

• Hankinson T, Tubbs RS, Wellons JC. Duraplasty or not? An evidence-based review of the pediatric Chiari I malformation. Childs Nerv Syst. 2011 Jan;27(1):35-40. doi: 10.1007/s00381-010-1295-7. Epub 2010 Oct 2.
• Shamji MF, Ventureyra EC, Baronia B, Nzau M, Vassilyadi M. Classification of symptomatic Chiari I malformation to guide surgical strategy. Can J Neurol Sci. 2010 Jul;37(4):482-7. doi: 10.1017/s0317167100010507.
• 2. Meadows J, Guarnieri M, Miller K, Haroun R, Kraut M, Carson BS. Type I Chiari malformation: a review of the literature. Neurosurg Q. 2001;11: 220-229.
• Dones J, De Jesus O, Colen CB, Toledo MM, Delgado M. Clinical outcomes in patients with Chiari I malformation: a review of 27 cases. Surg Neurol. 2003 Aug;60(2):142-7; discussion 147-8. doi: 10.1016/s0090-3019(03)00131-9.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Nervous System Malformations; Neural Tube Defects; Congenital Abnormalities; Arnold-Chiari Malformation
• Other Study ID Numbers: Chiari I surgical treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No