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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
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).
Primary Children's Medical Center
Salt Lake City, Utah, United States
GERD-related hospitalization and ED visits
Parental interviews and chart reviews will be used to record all health care encounters. Each encounter will be classified as either GERD-related or not. GERD-related hospitalizations and ED visits will be further classified as; diagnostic testing, procedural problems, likely aspiration pneumonia (AP or bacterial pneumonia), respiratory distress of other etiology, or death from any cause.
Time frame: 12 months
Health Related Quality of Life
These are a series of surveys about the child and caregiver's health related quality of life.
Time frame: 12 months
Total length of stay
This is the length of stay for each hospitalization and ED visit.
Time frame: 12 months
Complications from treatment
This will be monitored with hospitalizations (primary outcome)
Time frame: 12 months
Complications from failure of treatment
This will be monitored with hospitalizations (primary outcome), and will include things such as repeat procedure for fundoplication arm, ongoing need for GERD medications, and treatment cross-over.
Time frame: 12 months
Mortality
Any cause captured at 28 days and 12 months post procedure. Procedure related deaths will also be captured.
Time frame: 12 months
Costs related to hospital, ED, outpatient, and home-health care
This will be abstracted from hospital administrative database.
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Time frame: 12 months
Nutritional outcomes
Nutritional outcomes will be measured through anthropomorphic measurements including: * weight for age z-score * tibial length * triceps and subscapular skinfold thickness
Time frame: 12 months
Other outpatient health care
This will include primary care provider, neurology, gastroenterology, surgery, physiotherapy, etc.
Time frame: 12 months
Symptom control
We will ask parents/caregivers to evaluate their childs symptoms and severity.
Time frame: 12 months
Parental Goals of either treatment for GERD
We will ask parents/caregivers their goals for treatment and evaluate if they have been met.
Time frame: 12 months
Physician Goals of either treatment for GERD
We will ask physicians their goals for treatment and evaluate if they have been met.
Time frame: 12 months