No registrations found.
ID
Source
Health condition
Sagittal synostosis, patient related outcome measure, surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
response to questionnaire, represented and analysed on ordinal scale. Correlation with cranial index and photographic outcome score.
Secondary outcome
correlation with age at surgery, type of intervention, signs and symptoms of raised intracranial pressure
Background summary
Analysis of Patient Reported Outcome Measure after correction for sagittal suture
synostosis and validation with other outcome parameters.
Early closure of the sagittal suture results in restricted growth of the skull width
and compensatory growth of the skull length. The resulting head shape is called
scaphocephaly. Surgical remodeling of the skull is performed within the first year of life
for functional and cosmetic reasons (1).
Cosmetic results are difficult to score in an objective fashion.
An important method to asses cosmetic results to ask the patient about their satisfaction
with the cosmetic results in a standardized questionnaire called Patient-Reported
Outcome Measure (PROM)(2).
The goal of this study is to develop an outcome parameter that adequately reflects the
patients appreciation of the cosmetic result of remodeling. The questionnaire consists of
10 questions to be answered on a 5 point scale. The PROM will be validated with other
outcome parameters like Cranial Index and photographic scores.
The PROM will be send to patients between 6 and 18 years old who underwent surgery
in their first year of life in the Dutch Craniofacial Center for sagittal suture synostosis.
References
1. Wong KW, Forrest CR, Goodacre TE, Klassen AF. Measuring outcomes in
craniofacial and pediatric plastic surgery. Clinics in plastic surgery. 2013 Apr;40(2):305-
12.
2. Pusic AL, Lemaine V, Klassen AF, Scott AM, Cano SJ. Patient-reported outcome
measures in plastic surgery: use and interpretation in evidence-based medicine. Plastic
and reconstructive surgery. 2011 Mar;127(3):1361-7.
Study design
One observation between the age of 6 and 18 years
Intervention
1 questionnaire
Dutch Craniofacial Center <br>
Erasmus University Medical Center Rotterdam
M.L.C. Veelen, van
Rotterdam
The Netherlands
m.l.c.vanveelen@erasmusmc.nl
Dutch Craniofacial Center <br>
Erasmus University Medical Center Rotterdam
M.L.C. Veelen, van
Rotterdam
The Netherlands
m.l.c.vanveelen@erasmusmc.nl
Inclusion criteria
patients who underwent correction for sagittal synostosis at the dutch craniofacial study and are momentarily between 6 and 18 years old.
Exclusion criteria
Patients that do not meet the age criteria to fill in the questionnaire.
Patients with complex synostosis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4554 |
NTR-old | NTR4697 |
Other | : MEC-2014-445 |