NCT01307982

Comparative Anti-Reflux Procedures in Neurologically Impaired Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents with functional and intellectual impairment who have gastrostomy feeding tubes and medically refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to establish feasibility before initiating a multi-centered study.

Conditions

• Gastroesophageal Reflux
• Nervous System Diseases
• Fundoplication
• Enteral Nutrition

Interventions

Type	Name	Description
PROCEDURE	Fundoplication	During fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily.
PROCEDURE	Gastrojejunal (GJ) feeding tube	Gastrojejunal (GJ) tube placement is an image guided technique in which a special soft feeding catheter is placed through an existing hole in the stomach (gastrostomy) into the small bowel (jejunum).

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-03-03
• Last updated: 2013-10-21

Locations

1 site across 1 country: United States