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
About this trial
This is an interventional treatment trial for Craniosynostoses focused on measuring Surgical treatment modalities and outcome
Eligibility Criteria
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
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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Craniosynostosis :Surgical Treatment Modalities and Outcome
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