Severe obesity combined with gastroesophageal reflux disease Digestive System Obesity
Conditions
Interventions
Laparoscopic fundoplication + great curvature gastric plication compared to "Floppy Nissen" laparoscopic fundoplication
Sponsors
Scientific and Educational Centre for Development of Laparoscopic Surgery in Kazakhstan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adult participants aged over 16 2. Severe obesity combined with gastroesophageal reflux disease: BMI 35 - 39 kg/m2 (obesity class II) and no previous abdominal surgeries in the past.
Exclusion criteria
Exclusion criteria: 1. The refusal of a patient to have surgery and/or to participate in the ongoing study at any stage of the study 2. Conversion of laparoscopic surgery to open (traditional) surgery 3. Diseases of other organs and systems, the treatment of which could affect the course of reflux disease. 4. BMI less than 30 and more than 39 kg/m2. 5. Presence of a large diaphragmatic hernia 6. The degree of shortening of the esophagus 2 7. Patients who have had surgery in the cardioesophageal area 8. Patients who have had surgery within the abdominal cavity 9. No need for other simultaneous operations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. X-ray test performed with barium contrast 2. Esophagogastroscopy before the surgery and 1, 3, 6, 12 and 24 months after the surgery 3. 24hr pH monitoring of the esophagus lower third post-surgery 4. Body weight in kg | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The DeMeester score reflecting ?? at gastroesohageal junction, within 1-24 months after the surgery 2. Bariatric effectiveness assessed by excessive weight loss percentage (%EWL) | — |
Countries
Kazakhstan
Outcome results
None listed