Page 80 - Effects and Efficacy of (Laparoscopic) Gastrostomy Placement in Children - Josephine Franken

MeTHoDs
study design
A prospective, longitudinal cohort study was performed including pediatric patients who underwent GP in the Wilhelmina Children’s Hospital between May 2012 and April 2014. Exclusion criteria were refusal or inability of patients or caregivers to undergo the clinical tests, technical failure of 24-hour MII-pH metry and/or removal of the gastrostomy. Patient characteristics of non-responders were also recorded for adequate comparison of both patient groups. Patients underwent clinical assessment for GER before and 3 months after surgery.
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 Netherlands Trial Registry (NTR3314, 29-02-2012). Ethical approval was obtained from the University Medical Centre Utrecht Ethics Committee. Prior to initiating any study procedure, informed consent was obtained from the patients’ caregivers and the patients themselves, when 12 years or older and without NI.
surgical procedure
Laparoscopic GP was performed under general anaesthesia in all children. All procedures were performed or supervised by an experienced pediatric surgeon. An infra-umbilical 6 mm trocar was introduced for the camera. The position of the gastrostomy was determined between the umbilicus and the costal margin. A small incision was made introducing a Babcock clamp to grasp the ventral wall of the gastric corpus under direct laparoscopic view. After pulling up the corpus, the gastric wall was sutured to the fascia of the abdominal wall with four interrupted Vicryl 4-0 sutures. After insufflation of the stomach, a needle was inserted through the stomach wall. Using the Seldinger technique, a peel-away dilator was placed followed by insertion of a gastrostomy tube. The gastrostomy balloon was inflated with sterile water.
Clinical assessment
Patients underwent clinical assessment before and 3 months after surgery. GER analysis was performed with a reflux-specific symptom questionnaire and 24-hour MII-pH monitoring. Additionally, gastric emptying tests were performed with the 13C-octanoic acid breath test. 18 Data regarding feeding regimen, alternative feeding tube, weight and height, complications and reinterventions were collected with a gastrostomy-specific questionnaire.
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