N/A
N=53
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
Gastroesophageal Reflux Disease · Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00951093 ↗Enrolled (actual)
53
Serious AEs
—
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants Presenting Reflux Symptoms — 31; 8; 5 participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gastric bypass (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinica Gastrobese
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Presenting Reflux Symptoms |
31; 8; 5 | <0.001 sig |
| PRIMARY Number of Participants With Esophageal Injury |
24; 17; 10 | 0.002 sig |
| PRIMARY Number of Participants With Gastroesophageal Reflux Disease (GERD) |
34; 21; 12 | < 0.001 sig |
| PRIMARY Total Esophageal Acid Exposure at 24h pH Monitoring |
5.1; 1.2; 0.1 | < 0.020 sig |
| PRIMARY Esophageal Acid Exposure at 24h pH Monitoring in Upright Position |
5.9; 0.8; 0.1 | < 0.001 sig |
| PRIMARY Esophageal Acid Exposure at 24h pH Monitoring in Supine Position |
1.8; 0.5; 0.0 | 0.001 sig |
| PRIMARY Number of Participants With Increased Acid Exposure |
31; 16; 9 | < 0.001 sig |
Summary
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
Eligibility Criteria
Inclusion Criteria
- Morbid obesity
- Acceptance to undergo open gastric bypass
Exclusion Criteria
- Prior gastroesophageal surgery
- Achalasia
Data sourced from ClinicalTrials.gov (NCT00951093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.