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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06029101
Collaborator
(none)
12
1
1
17.1
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: posterior fossa craniectomy with or without duraplasty
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital . [4 weeks postoperative]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Hamdy Hussein, demonistrator, Assiut University
ClinicalTrials.gov Identifier:
NCT06029101
Other Study ID Numbers:
  • Chiari I surgical treatment
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023