Gastroesophageal Reflux, Obesity
Conditions
Keywords
Obesity, Gastroesophageal reflux, sleeve gastrectomy, pH-monitoring, manometry
Brief summary
Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking. The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.
Detailed description
Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.
Interventions
None listed
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* history of obesity exceeding 5 years * documented previous weight loss attempts, * body mass index (BMI)) of 40-50 kg/m2 * age of 18-60 years.
Exclusion criteria
* contraindications to pneumoperitoneum * large esophageal hiatal hernia * pregnancy, * drug or alcohol abuse, * psychological disorders (e.g., bulimia, depression) * hormonal or genetic obesity-related disease, * previous gastric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in DeMeester's score | baseline, 24 months after LSG | Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lower esophageal sphincter pressure | baseline, 24 months after LSG | Esophageal manometry measures several parameters including lower esophageal sphincter pressure |
| Change from baseline in amplitude of esophageal peristaltic waves | baseline, 24 months after LSG | Esophageal manometry evaluates quality and amplitude of esophageal peristalsis |
| Change from baseline in grade of esophagitis | baseline, 24 months after LSG | Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis |
| Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score | Baseline, 24 months after LSG | Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life |
Countries
Italy
Outcome results
None listed