Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05511168 |
| Other study ID # |
Craniosynostosis:outcome |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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
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).
