Craniosynostosis :Surgical Treatment Modalities and Outcome

August 19, 2022 updated by: Mohamed Amgad Kotb, Assiut University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients either syndromic or nonsyndromic

Exclusion Criteria:

  • • Patients aged less than 3 month

    • Patients had bad general condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Craniosynostosis patients
Craniosynostotic patients aged more than 3months
Procedure: Craniostnostosis surgery
Surgery of craniosynostosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cosmosis
Time Frame: 1 year
cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
intraoperative bleeding
Time Frame: 1 year
Volume of blood lost in the operation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Craniosynostosis:outcome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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