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CraniosynostosesNCT05511168

Craniosynostosis :Surgical Treatment Modalities and Outcome

A study testing Craniostnostosis surgery in people with Craniosynostoses, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim of study: 1. To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery 2. - To ascertain intra- and postoperative complications Read more about this study

Who is it for?
Ages 3 months to 8 yearsHealthy volunteers can take part
Conditions the study is for
Craniosynostoses
What is being tested?
Craniostnostosis surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Oct 2023
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 3 months to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • all patients either syndromic or nonsyndromic

Who cannot join

  • • Patients aged less than 3 month
  • Patients had bad general condition

About this study

Official title: Craniosynostosis : Surgical Treatment Modalities and Outcome

Aim of study:

  1. To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery
  2. - To ascertain intra- and postoperative complications
Read the detailed description

Craniosynostosis is defined as the premature fusion of one or more of the sutures normally separating the infant's skull bony plates, resulting in abnormal growth of the cranial vault and skull base, which may influence brain growth and development(1).

Aetiology Primary Craniosynostosis: No cause for the synostosis is recognized in the majority of cases, , but in an increasing proportion (currently about 25%), a mutation is identified. A considerable proportion of these mutations are related to six genes FGFR2, FGFR3, TWIST1, EFNB1, TCF12 and ERF(2).

Types of Craniosynostosis Non-syndromic (or isolated), in which only the skull is affected, The syndromic craniosynostosis is caused by an inherited or genetic condition and associated with craniofacial syndromes(3).

Syndromic craniosynostosis is most commonly found in:

  • Apert syndrome
  • Crouzon syndrome
  • Muenke syndrome
  • Pfeiffer syndrome
  • Saethre-Chotzen syndrome(4)

Diagnosis:

The skull shape from all directions, and the measurement of the head circumference for calculating the cephalic index (the ratio of maximum breadth to maximum length of the skull). Any sutural ridging, prominent blood vessels on the scalp, and the size, shape and tension of the fontanels should also be assessed.

For evaluating ICP, ophthalmological examination is of great importance. In cases with increased ICP, papilledema is present To confirm the diagnosis The computed tomography (CT) with three-dimensional (3D) reconstruction is considered the most complete and accurate imaging to diagnose craniosynostosis the magnetic resonance imaging (MRI) is an excellent technique for the evaluation of brain(5).

Many types of craniosynostosis require surgery. The surgical procedure is done to relieve pressure on the brain, correct the craniosynostosis, and permit the brain to grow appropriately. Babies with very mild craniosynostosis might not need surgery. Delay surgical intervention causes irreversible loss of vision and permanent cognitive impairment.

a neglected case of craniostenosis, presented with deformity of head with mental retardation, which was operated after delay lead to poor neurological outcome(6).

Surgical management for craniosynostosis is based on the suture(s) involved, the age of the child, and the individual needs for each patient.

  • Strip craniectomy
  • Sagittal springs also known as cranial spring surgery
  • Fronto-orbital advancement /reshaping
  • Cranial vault remodeling and reconstruction.
  • Posterior vault distraction osteogenesis (7) Outcome variables debated include magnitude and durability of head shape improvement, cost, neurodevelopmental trajectory, burden of care to patient, and intra- and postoperative complication rates(8).

Most frequent complication was non-filiated postoperative hyperthermia followed by infection , subcutaneous haematoma), dural tears and cerebrospinal fluid (CSF) leakage. Number and type of complications was higher among the group of reoperated patients (9).

Being tested
Craniostnostosis surgery
Keywords
Surgical treatment modalities and outcome
Medical subject headings
Craniosynostoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Craniostnostosis surgeryProcedure or surgery

    Surgery of craniosynostosis

Study groups in NCT05511168
Study groupRoleWhat they receive
Craniosynostosis patientsOtherCraniosynostotic patients aged more than 3months
Receives: Procedure: Craniostnostosis surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cosmosis

    cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index

    Measured: 1 year

Secondary outcomes (1)
  1. intraoperative bleeding

    Volume of blood lost in the operation

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511168
Sponsor's protocol ID
Craniosynostosis:outcome
Status last verified
Aug 2022
First submitted
16 Aug 2022
Last updated
22 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Craniostnostosis surgery in people with Craniosynostoses, run by Assiut University.

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 1 inclusion and 2 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cosmosis (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Aug 2022.

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