Page 64 - Effects and Efficacy of (Laparoscopic) Gastrostomy Placement in Children - Josephine Franken

ethical approval and trial registration
The study was registered at the Dutch trial register before the start of the study (NTR3314, 29-02-2012). Ethical approval was obtained from the University Medical Center Utrecht Ethics Committee. Prior to initiating any study procedure, informed consent was obtained from the patients’ parents and the patients themselves (when 12 years or older and not neurologically impaired (NI)).
surgical procedure
In all children a laparoscopic GP was performed under general anaesthesia. 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 sutures. After insufflation of the stomach, a needle was inserted through the gastric 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.
On the first day after surgery, enteral feeding through the gastrostomy was initiated with half of the normal feeding regimen. On the second postoperative day, full enteral feeding was administered.
Clinical assessment
Patients underwent clinical assessment before and 3 months after GP. Clinical outcomes were analysed with the 13CGEBT for GE analysis and with 24-hour pH monitoring for GER analysis. Additionally, parents and children without NI over 12 years of age filled out a reflux-specific questionnaire for GER symptoms.
Gastric emptying test
GE was assessed with the 13CGEBT. For this 13CGEBT, the stable isotope 13C labeled Na- octanoate is added to a solid or liquid test meal. This test has proven to be a reliable, safe and non-invasive diagnostic method for GE in children. In contrast to 99-Technetium scintigraphy, the former gold standard for GE, it offers normal values for children of all ages, both genders and liquid and solid intake. Additionally, 13CGEBT does not involve radiation and is therefore suitable for large pediatric study populations. 13 The intra- individual variability of the 13CGEBT has been studied in multiple studies. Hauser et al. found a coefficient of intrasubject variation of 12.5, which was comparable to the results of other
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