CHANGES IN GERD AFTER GASTRIC BANDING - RELATION WITH ESOPHAGEAL FUNCTION PARAMETERS AND OTHER POSSIBLE PREDICTIVE FACTORS

Withdrawn

• Conditions: Gastroesophageal reflux disease; GERD; reflux complaints; 10017977

• Registration Number: NL-OMON33684
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- BMI > 40 or BMI > 35 with comorbidity
- Reflux complaints (RDQ > 0)
- Positive screening in Nederlandse Obesitas Kliniek for laparoscopic gastric band placement

Exclusion Criteria

- Severly disordered esophageal motility ( < 20 mmHg mean contraction amplitude in the lower esophagus and less than 50% peristaltic contractions)
- 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 identification of predictive factors in the pattern of reflux complaints<br /><br>and impaired esophageal transit before and after gastric banding, as measured<br /><br>with manometry and pH/impedance monitoring. Therefore, patients in which reflux<br /><br>complaints decrease, increase or stay unchanged postoperatively will be<br /><br>compared with each other.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- LES pressure<br /><br>- % reflux / 24 hours<br /><br>- Body Mass Index<br /><br>- Waist Circumference</p><br>