Laparoscopic surgery for severe obesity and related metabolic disorders Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age over 18 and below 65 years 2. BMI over 40 kg/m² (without comorbidity related to morbid obesity) or 35 kg/m² (with comorbidity related to morbid obesity, especially glucose metabolism) 3. Patient agreement for follow-ups 4. Obtained informed consent
Exclusion criteria
Exclusion criteria: 1. Bariatric surgery in previous history 2. Severe mental disorders (drug addiction, alcohol consumption, the use of antipsychotics) 3. Socially vulnerable patients 4. Complete immobilization 5. Patients who did not understand the purpose of the study and bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complications (gastric wall prolapse, leakage, stricture, bleeding, bile reflux, vomiting, diarrhea, hair loss, nutrient deficiency, hypoproteinaemia and anaemia due to malabsorption, venous thromboembolism, pulmonary and cardiovascular events, 30-day hospital readmission) were classified by Clavien-Dindo | — |
Secondary
| Measure | Time frame |
|---|---|
| At follow up visits (1,3,6 and 12 months), patients were assessed again by physical examination, blood tests (blood count, ionogram, serum protein, glucose, HgbA1C, iron binding capacity, lipid profile, kidney and liver function, hemostasis) and BAROS-Moorehead-Ardelt II and Weiner et al. questionnaires. Weight, BMI adjusted to age-gender-ethnics, ideal weight (at BMI: 25), excess of weight, excess of BMI, weight loss, EWL% and TWL% were measured as weight loss outcomes | — |
Countries
Hungary