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Analysis of patient reported outcome after correction of sagittal synostosis


- candidate number18445
- NTR NumberNTR4697
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jul-2014
- Secondary IDsMEC-2014-445 
- Public TitleAnalysis of patient reported outcome after correction of sagittal synostosis
- Scientific TitleAnalysis of patient reported outcome measure and validation against cranial measurements and photographic outcome scores.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedCraniosynostosis, Surgery, Patient reported outcomes
- Inclusion criteriapatients who underwent correction for sagittal synostosis at the dutch craniofacial study and are momentarily between 6 and 18 years old.
- Exclusion criteriaPatients that do not meet the age criteria to fill in the questionnaire.
Patients with complex synostosis.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate1-okt-2015
- Target number of participants120
- Interventions1 questionnaire
- Primary outcomeresponse to questionnaire, represented and analysed on ordinal scale. Correlation with cranial index and photographic outcome score.
- Secondary outcomecorrelation with age at surgery, type of intervention, signs and symptoms of raised intracranial pressure
- TimepointsOne observation between the age of 6 and 18 years
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.L.C. Veelen, van
- CONTACT for SCIENTIFIC QUERIES M.L.C. Veelen, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryAnalysis 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.
- Main changes (audit trail)
- RECORD17-jul-2014 - 23-aug-2014


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