Study Comparing Two Sizes of Gastrostomy Tubes in Children and Their Effect on Postoperative Complications

What this Trial Is About

Researchers are investigating whether the thickness of gastrostomy tubes affects the rate of postoperative complications in children who need long-term enteral nutrition. This study compares two tube sizes, 12 Fr and 14 Fr, to see if a smaller tube might reduce issues such as granuloma, infection, pain, dislocation, and leakage. Gastrostomy is a common procedure in children with conditions like neurological diseases and metabolic disorders, and the study aims to provide clearer guidance on tube size choice. Children scheduled for laparoscopic gastrostomy are randomly assigned to receive either a 12 Fr or 14 Fr gastrostomy tube. After surgery, the tubes are changed at three months following national guidelines. Both families and healthcare personnel complete questionnaires about any complications experienced during this period. The data collected will be analyzed to determine if tube size influences complication rates. Participants will have a gastrostomy placed and then return for a follow-up visit three months later when the tube is changed. During this visit, questionnaires about complications such as granuloma formation, infection, pain, dislocation, and leakage will be completed by nurses and caregivers. The study will collect and analyze this information to assess outcomes. Participation involves surgery, follow-up care, and data collection over a three-month postoperative period.

Does the Thickness of the Gastrostomy Affect the Incidence of Complications? A Prospective Randomized Single-Center Study in Children