Changes in GERD after gastric banding - relation with esophageal function parameters and other possible predicitve factors
Withdrawn
- Conditions
- complaints of heartburn and regurgitationGastroesophageal reflux disease (GERD)10017977
- Registration Number
- NL-OMON33304
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
- BMI > 40 or > 35 kg/m2 with obesity related comorbidity
- Reflux complaints (assessed with Reflux Disease Questionnaire)
- Positive screening in Nederlandse Obesitas Kliniek for laparoscopic gastric band placement
Exclusion Criteria
- Severly disordered esophageal motility (<20 mmHg mean contraction amplitude in het lower esophagus and less than 50% peristaltic contractions)
- Unability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
- Endocrine disease causing overweight (hypothyroidism, hypercortisolism)
- Binge-eating disorder or associated eating disorders
- Active drug or alcohol addiction
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The outcome of reflux complaints after gastric banding (increase, steady state<br /><br>or decrease)<br /><br><br /><br>Outcome parameters:<br /><br>- esophageal motility (assessed with high resolution manometry)<br /><br>- reflux characteristics (assessed with pH/impedance monitoring)<br /><br>- endoscopic findings (assessed with gastroscopy)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Esophageal motility: LES pressure, % peristaltic contractions, mean contractile<br /><br>amplitude<br /><br>pH/impedance monitoring: % reflux/24 h, frequention reflux episodes, acid or<br /><br>non-acid, gaseous or liquid)<br /><br>Patient characteristics: decrease BMI, waist circumference</p><br>