Condition 1: severe obesity. Condition 2: Bariatric surgery status. Condition 3: Gastro-esophageal reflux disease without esophagitis. Condition 4: Gastro-esophageal reflux disease with esophagitis. Morbid (severe) obesity due to excess calories Bariatric surgery status Gastro-esophageal reflux disease without esophagitis Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention 1: Intervention group: Concomitant cruroplasty with routine sleeve gastrectomy. The sleeve is performed after releasing the stomach from the surrounding soft-tissue and omentum. Next, par
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Have indications for bariatric procedure according to ASMBS guideline (i.e. body mass index>40 kg/m2) Normal gastroesophageal junction view on endoscopy No hiatal hernia on endoscopy H.pylori stool antigen negative No history of gastroesophageal reflux disease symptoms No history of consuming PPIs or antibiotics Willingness to participate in this study Age within 20-60 years old
Exclusion criteria
Exclusion criteria: Not willing to participate in this study Pregnancy during the follow-up Severe or uncontrolled psychological disease Not respecting to the dietician and supplement use protocols Not participating in postoperative follow-up visits Not willing to do postoperative endoscopy >20% lack in medical document data Finding hiatal hernia during the operation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of GERD clinical manifestations. Timepoint: before-after the surgery. Method of measurement: Taking history of reflux symptoms e.g. heartburn, regurgitation. | — |
Secondary
| Measure | Time frame |
|---|---|
| GERD-Quality of Life questionnaire score. Timepoint: change in score before-after the surgery. Method of measurement: GERD-QL questionnaire.;Evidence of reflux in gastroesophageal endoscopy. Timepoint: before-after the surgery. Method of measurement: gastroesophageal endoscopy.;Evidence of hiatal hernia in endoscopy. Timepoint: before-after surgery. Method of measurement: upper endoscopy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahab Shahabi
Esfahan University of Medical Sciences
Outcome results
None listed