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

Primary Purpose

Chiari Malformation, Type 1

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
posterior fossa craniectomy with or without duraplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chiari Malformation, Type 1

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chiari I malformation patients undergoing craniectomy

Arm Description

modalities and outcomes of surgical treatment of chiari I malformation patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2023
Last Updated
September 6, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT06029101
Brief Title
Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes
Official Title
Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chiari Malformation, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chiari I malformation patients undergoing craniectomy
Arm Type
Experimental
Arm Description
modalities and outcomes of surgical treatment of chiari I malformation patients
Intervention Type
Procedure
Intervention Name(s)
posterior fossa craniectomy with or without duraplasty
Intervention Description
craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.
Primary Outcome Measure Information:
Title
Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .
Description
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.
Time Frame
4 weeks postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hamdy Hussein, demonstrator
Phone
01103960297 - 01020836040
Email
ahmedhamdyhussein@med.nvu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Taha, lecturer
Phone
01006268779
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Taghian, professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Abdallah, Ass. prof
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ismail Taha, lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
20724256
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
20890606
Citation
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.
Results Reference
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PubMed Identifier
12900124
Citation
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.
Results Reference
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Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes

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