Craniosynostosis :Surgical Treatment Modalities and Outcome

Craniosynostosis : Surgical Treatment Modalities and Outcome

Aim of study:

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

Study Overview

• Status: Not yet recruiting
• Conditions: Craniosynostoses
• Intervention / Treatment: Procedure: Craniostnostosis surgery

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients either syndromic or nonsyndromic

Exclusion Criteria:

• • Patients aged less than 3 month

  • Patients had bad general condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmosis	cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative bleeding	Volume of blood lost in the operation	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Surgical treatment modalities and outcome
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Craniosynostoses
• Other Study ID Numbers: Craniosynostosis:outcome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No