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Craniosynostosis :Surgical Treatment Modalities and Outcome

Primary Purpose

Craniosynostoses

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Craniostnostosis surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniosynostoses focused on measuring Surgical treatment modalities and outcome

Eligibility Criteria

3 Months - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients either syndromic or nonsyndromic

Exclusion Criteria:

  • • Patients aged less than 3 month

    • Patients had bad general condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Craniosynostosis patients

    Arm Description

    Craniosynostotic patients aged more than 3months

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    intraoperative bleeding
    Volume of blood lost in the operation

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05511168
    Brief Title
    Craniosynostosis :Surgical Treatment Modalities and Outcome
    Official Title
    Craniosynostosis : Surgical Treatment Modalities and Outcome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (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
    Aim of study: To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery - To ascertain intra- and postoperative complications
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Craniosynostoses
    Keywords
    Surgical treatment modalities and outcome

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Craniosynostosis patients
    Arm Type
    Other
    Arm Description
    Craniosynostotic patients aged more than 3months
    Intervention Type
    Procedure
    Intervention Name(s)
    Craniostnostosis surgery
    Intervention Description
    Surgery of craniosynostosis
    Primary Outcome Measure Information:
    Title
    Cosmosis
    Description
    cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    intraoperative bleeding
    Description
    Volume of blood lost in the operation
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: all patients either syndromic or nonsyndromic Exclusion Criteria: • Patients aged less than 3 month Patients had bad general condition

    12. IPD Sharing Statement

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