excess stomach acid GERD
Conditions
Interventions
All 80 patients will undergo an additional pre-operative and three and 12
months postoperative combined pH-impedance and high-resolution manometry (HRM)
examination in addition to the standard pre-a
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18-65 years - Body Mass Index (BMI) of *40 or *35 with significant comorbidity, with an indication for LSG - Fit for surgery
Exclusion criteria
Exclusion criteria: - Age 65 years - No informed consent - History of GERD, reflux esophagitis or Barrett*s esophagus - History of, or intraoperatively diagnosed, paraesophageal hernia (type II) or mixed (type III), or hiatal hernia > 5,0 cm - Previous anti-reflux surgery, HH repair or previous bariatric surgery - Pregnant - Severe esophageal motility disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the differences in total esophageal acid exposure between patients (diagnosed with small HH) who underwent either LSG alone or LSG+HHR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints consist of 1) changes in prevalence and intensity of GERD symptoms, dysphagia symptoms, and quality of life based on validated questionnaires between these two groups, 2) changes in belching, the number of acid and weakly acidic reflux episodes and manometric changes, 3) the effect of LSG on total esophageal acid exposure, weakly acid exposure and manometric changes in patients with no intraoperatively diagnosed HH who underwent LSG alone and (4) changes in anti-reflux medication usage in both groups of patients within the HH-group and patients in the no-HH-group. | — |
Countries
Netherlands
Outcome results
None listed