Antireflux surgery in pediatric GERD patients.
Recruiting
- Conditions
- gastroesophageal reflux, antireflux surgery, fundoplication, children
- Registration Number
- NL-OMON26312
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
Inclusion Criteria
Children (0-18yrs) with severe GERD:
1. Referred for antireflux surgery by a pediatrician/pediatric gastroenterologist and;
Exclusion Criteria
1. Inability to undergo investigation;
2. Prior esophageal and/or gastric surgery, except gastrostoma.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of failed antireflux procedures:<br /><br>1. Percentage time pH <4 (total time > 4%);<br /><br>2. Number of reflux episodes/24hr (> 9);<br /><br>3. Number of reflux episodes longer than 5 minutes (> 4);<br /><br>4. Symptom scores (symptoms ≥ moderate-severe and/or daily-weekly);<br /><br><br /><br /><br>Gastroesophageal function/motility:<br /><br>1. Lower esophageal sphincter relaxation (% complete relaxation);<br /><br>2. Percentage peristaltic contractions esophagus (%);<br /><br>3. Contractions proximal/mid/distal esophagus (mmHg);<br /><br>4. Gastric half-emptying time (min) as measured by 13C octanoic acid breath test;<br /><br>5. Maximal proximal gastric adaptive relaxation (ml) as measured by 3D-US.<br><br /><br /><br>Success is defined as:<br /><br>1. Complete symptom relief and normalised pH metry;<br /><br>2. Complete symptom relief and near-normal pH metry;<br /><br>3. Normalized pH metry and significant improvement of reflux symptoms (complaints less than mild/monthly).
- Secondary Outcome Measures
Name Time Method Health-related quality of life.