|- candidate number||18445|
|- NTR Number||NTR4697|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jul-2014|
|- Secondary IDs||MEC-2014-445 |
|- Public Title||Analysis of patient reported outcome after correction of sagittal synostosis|
|- Scientific Title||Analysis of patient reported outcome measure and validation against cranial measurements and photographic outcome scores.|
|- Healt Condition(s) or Problem(s) studied||Craniosynostosis, Surgery, Patient reported outcomes|
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-okt-2015|
|- Target number of participants||120|
|- Interventions||1 questionnaire|
|- 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|
|- Timepoints||One observation between the age of 6 and 18 years|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| M.L.C. Veelen, van|
|- CONTACT for SCIENTIFIC QUERIES|| M.L.C. Veelen, van|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief 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.
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-
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.
|- Main changes (audit trail)|
|- RECORD||17-jul-2014 - 23-aug-2014|