Chiari Malformation, Type 1NCT06029101
Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes
A study testing posterior fossa craniectomy with or without duraplasty in people with Chiari Malformation, Type 1, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital . Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chiari Malformation, Type 1
- What is being tested?
- posterior fossa craniectomy with or without duraplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations.
- Patients fit for surgery
Who cannot join
- Other types of Chiari malformations
- Patients with multilevel cervical disc herniation .
- Patients with segmental instability .
- Patients unfit for surgery
Trial locations and contacts
1 site in 1 country.
Ismail Taha, lecturer contact
About this study
Evaluation of postoperative outcomes of Chiari type I Malformation Patients at Department of Neurosurgery Assiut University Hospital .
Read the 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).
- Conditions
- Chiari Malformation, Type 1
- Being tested
- posterior fossa craniectomy with or without duraplasty
- Medical subject headings
- Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior fossa craniectomy with or without duraplastyProcedure or surgery
craniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils.
| Study group | Role | What they receive |
|---|---|---|
| chiari I malformation patients undergoing craniectomy | Experimental | modalities and outcomes of surgical treatment of chiari I malformation patients Receives: Procedure: posterior fossa craniectomy with or without duraplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Apr 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chiari Malformation, Type 1Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamdy Hussein, Assiut University
- Investigators
- Mohamed Taghian, professor, Study chair, Assiut UniversityAhmed Abdallah, Ass. prof, Study director, Assiut UniversityIsmail Taha, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029101
- Sponsor's protocol ID
- Chiari I surgical treatment
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 207242562. 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.
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.
PubMed 20890606Dones 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.
PubMed 12900124
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modalities of Surgical Treatment of Chiari Malformation Disease : Clinical Study and Outcomes
- ClinicalTrials.gov ID
- NCT06029101
- Acronym / sponsor ID
- Chiari I surgical treatment
- Conditions
- Chiari Malformation, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chiari I malformation patients undergoing craniectomy | Experimental | Procedure: posterior fossa craniectomy with or without duraplastymodalities and outcomes of surgical treatment of chiari I malformation patients |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Chiari I Malformation patients who suffer from clinical symptoms and radiological manifestations.
- Patients fit for surgery
Key exclusion criteria (4 listed)
- Other types of Chiari malformations
- Patients with multilevel cervical disc herniation .
- Patients with segmental instability .
- Patients unfit for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior fossa craniectomy with or without duraplastycraniectomy of occipital bone and duroplasty with graft to expand the shallow posterior fossa and reposition the cerebellar tonsils. | Procedure or surgery | chiari I malformation patients undergoing craniectomy |
Primary outcome
Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital .
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 20724256Shamji 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.
- Background2. 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: PubMed 20890606Hankinson 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.
- Background: PubMed 12900124Dones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Taha, lecturer contact
Mohamed Taghian, professor study chair
Assiut University
Ahmed Abdallah, Ass. prof study director
Assiut University
Ismail Taha, lecturer study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior fossa craniectomy with or without duraplasty in people with Chiari Malformation, Type 1, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hamdy Hussein, demonstrator (01103960297 - 01020836040, ahmedhamdyhussein@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of postoperative outcomes of Chiari Malformation Patients at Department of Neurosurgery Assiut University Hospital . (time frame: 4 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06029101, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.