Page 116 - Effects and Efficacy of (Laparoscopic) Gastrostomy Placement in Children - Josephine Franken

because various studies on HRQoL in children indicate that information provided by caregivers does not always correspond to what children report themselves. 12
MeTHoDs
study design
Between May 2012 and April 2014, a prospective, longitudinal cohort study was performed including 50 pediatric patients that underwent laparoscopic GP at the Wilhelmina Children’s Hospital, University Medical Center Utrecht (UMCU). Clinical assessment was performed before GP and 3 months after operation.
surgical procedure
GP was performed laparoscopically under general anesthesia in all pediatric patients. All procedures were performed or supervised by an experienced pediatric surgeon. Operations were performed by 6 different pediatric surgeons.
ethical approval and trial registration
This study was part of a larger trial on GP in children, registered under the name of ‘The effect of laparoscopic gastrostomy on gastric emptying: A prospective observational study in children’ at the Dutch trial register (NTR3314, 29-02-2012).
Ethical approval for the study was obtained from the UMCU Ethics Committee. Prior to initiating any study procedure, informed consent was obtained from the patients’ parents or caregivers and the patients themselves (when 12 years or older and without NI).
Clinical assessment
Patient characteristics and medical history were derived from the patient records. Clinical assessment included the completion of the PedsQLTM. 8-10 Questionnaires were completed in proxy-report by caregivers for all children. Additionally, children without NI completed a version of the questionnaires in self-report.
The PedsQLTM is subdivided into four age-adjusted questionnaires (ages: 2-4; 5-7; 8-12 and 13-18 years) and a parallel self-report for children (ages: 5-7; 8-12 and 13-18 years). The inventory comprises 23 items. The total HRQOL score is divided into two main health scores: physical health summary score (8 items) and psychosocial health summary score (15 items), which in turn comprises the domains emotional scale score (5 items), social scale score (5 items), and functioning scale score (5 items). Scale scores per domain were computed as the sum of the items divided by the number of items answered. Items were
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