Fundoplication clinical trials

Health, Economic Analysis and Clinical Aspects of Patients With Neurological Disabilities in Enteral Nutrition With Dedicated Formula. The Role of Nissen's Fundoplication in the Management of Gastroesophageal Reflux

Nutritional difficulties are common in children with neurodisabilities and can be associated with malnutrition and gastrointestinal diseases, such as gastro-esophageal reflux disease (GERD) and constipation. Neurological disorders can be divided into two main categories: progressive (neurodegenerative, mitochondrial disease) and non-progressive (cerebral palsy) neurodisabilities; nature of the disorders can impair on the nutritional status of these children. In 2017, ESGHAN published guidelines with specific nutritional claims. Approximately 46%-90% of children with neurodisabilities suffer from malnutrition and an enteral feeding is necessary to reach the nutritional requirements. In addition, a relevant issue for these children is GERD, reaching up to 70% prevalence. The treatment of GERD could be based on pharmacological therapy (protonic pomp inhibitor, PPI), on nutritional treatment (changing type of formula) or on surgical treatment (Nissen Fundoplication). European guidelines for GERD recommend PPI as the first line, with fundoplication being considered in cases of failure of optimized medical therapy. Enteral feeding can be considered in order to avoid malnutrition and is justified when other efforts to increase nutritional intake. Enteral feeding can be provided by nasal tube at the beginning, but a gastrostomy feeding tube would be preferred for a long-term nutrition (greater than six weeks). A jejunal tube can be introduced through the gastrostomy; jejunal feeding is appropriate in patients with recurrent vomiting and/or tube feeding-related aspiration, severe gastroesophageal reflux, and gastroparesis. Different types of formulas can be used for enteral nutrition and can be offered by nasal tube, percutaneous endoscopic gastrostomy (PEG) or percutaneous endoscopic jejunostomy (PEJ). Whey-based formulas have been shown to empty from the stomach more rapidly than casein-based formulas, which may be helpful for patients presenting with delayed gastric emptying. Use of peptide-based, 100% whey protein formulas are associated with improved feeding tolerance, increased consistency in meeting nutritional needs, and a reduction in gastrointestinal issues associated with vomiting and aspiration of feeds. For these reasons, the aim of this study is to retrospectively evaluate the role of different formulas against Nissen fundoplication, regarding tolerance, utility, applicability and safeness of these products, by performing a cost analysis.