Craniosynostosis :Surgical Treatment Modalities and Outcome

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511168

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Aim of study:

To evaluate outcome of cases( cosmoses and cognition) after Craniosynostosis surgery
- To ascertain intra- and postoperative complications

Condition or Disease	Intervention/Treatment	Phase
Craniosynostoses	Procedure: Craniostnostosis surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Craniosynostosis : Surgical Treatment Modalities and Outcome

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Craniosynostosis patients Craniosynostotic patients aged more than 3months	Procedure: Craniostnostosis surgery Surgery of craniosynostosis

Arm

Intervention/Treatment

Other: Craniosynostosis patients

Craniosynostotic patients aged more than 3months

Procedure: Craniostnostosis surgery

Surgery of craniosynostosis

Outcome Measures

Primary Outcome Measures

Cosmosis [1 year]
cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index

Secondary Outcome Measures

intraoperative bleeding [1 year]
Volume of blood lost in the operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all patients either syndromic or nonsyndromic

Exclusion Criteria:

• Patients aged less than 3 month
Patients had bad general condition

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Amgad Kotb, Craniosynostosis: surgical treatment modalities and outcome, Assiut University

ClinicalTrials.gov Identifier:

NCT05511168

Other Study ID Numbers:

Craniosynostosis:outcome

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Amgad Kotb, Craniosynostosis: surgical treatment modalities and outcome, Assiut University

Surgical treatment modalities and outcome

Additional relevant MeSH terms:

Craniosynostoses

Study Results

No Results Posted as of Aug 22, 2022