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N/A Completed N=53

Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

Source: ClinicalTrials.gov NCT00951093 ↗
Enrolled (actual)
53
Serious AEs
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants Presenting Reflux Symptoms — 31; 8; 5 participants — p=<0.001

Summary

The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Outcome Measures

OutcomeResultp-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

Eligibility Criteria

Inclusion Criteria

  • Morbid obesity
  • Acceptance to undergo open gastric bypass

Exclusion Criteria

  • Prior gastroesophageal surgery
  • Achalasia
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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