NCT06029101

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

August 25, 2023

Last Update Submit

September 6, 2023

Conditions

Chiari Malformation, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

chiari I malformation patients undergoing craniectomy

EXPERIMENTAL

modalities and outcomes of surgical treatment of chiari I malformation patients

Procedure: posterior fossa craniectomy with or without duraplasty

Interventions

posterior fossa craniectomy with or without duraplastyPROCEDURE

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

chiari I malformation patients undergoing craniectomy

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations.
  • Patients fit for surgery

You may not qualify if:

  • Other types of Chiari malformations
  • Patients with multilevel cervical disc herniation .
  • Patients with segmental instability .
  • Patients unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 20724256BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20890606BACKGROUND

  • 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.

    PMID: 12900124BACKGROUND

MeSH Terms

Conditions

Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mohamed Taghian, professor

    Assiut University

    STUDY CHAIR

  • Ahmed Abdallah, Ass. prof

    Assiut University

    STUDY DIRECTOR

  • Ismail Taha, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Hamdy Hussein, demonstrator

CONTACT

01103960297 - 01020836040ahmedhamdyhussein@med.nvu.edu.eg

Ismail Taha, lecturer

CONTACT

01006268779

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonistrator

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 8, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

EG(1)