Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05511168
Study type Interventional
Source Assiut University
Contact
Status Not yet recruiting
Phase N/A
Start date September 1, 2022
Completion date October 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04159675 - Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts
Completed NCT04827524 - Investigation of Anthropometric Properties of Babies With Craniosynostosis
Recruiting NCT04695938 - Craniofacial Imaging With 3D MRI: an Alternative to Ionising Radiation N/A
Recruiting NCT04072783 - Neurodevelopmental Outcomes in Craniosynostosis Repair N/A
Suspended NCT01094977 - Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid Phase 3
Completed NCT04086056 - CraNIRS Clinical Study
Withdrawn NCT03812159 - Clinical Feasibility Study of Preoperative Surgical Planning N/A
Completed NCT04133467 - Scalp Block Decreases Pain and Side Effects
Terminated NCT03698838 - Myelin Imaging Changes In Patients With Neurosurgical Diseases
Recruiting NCT06263075 - Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)
Not yet recruiting NCT06366178 - EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses N/A
Completed NCT03915587 - Bedside Resources to Gauge Intravascular Volume Status N/A