NCT05511168

Brief Summary

Aim of study:

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 16, 2022

Last Update Submit

August 19, 2022

Conditions

Craniosynostoses

Keywords

Surgical treatment modalities and outcome

Outcome Measures

Primary Outcomes (1)

  • Cosmosis

    cosmosis of patients after Craniosynostosis surgery by these measures : Cephalic index

    1 year

Secondary Outcomes (1)

  • intraoperative bleeding

    1 year

Study Arms (1)

Craniosynostosis patients

OTHER

Craniosynostotic patients aged more than 3months

Procedure: Craniostnostosis surgery

Interventions

Craniostnostosis surgeryPROCEDURE

Surgery of craniosynostosis

Craniosynostosis patients

Eligibility Criteria

Age3 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • all patients either syndromic or nonsyndromic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

SynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Craniosynostosis: surgical treatment modalities and outcome

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 22, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08