This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
TWO HYPOABSORPTION TECHNIQUES FOR THE TREATMENT OF TYPE III OBESITY (BODY MASS INDEX BETWEEN 45 - 49.9 KG/M2): SINGLE ANASTOMOSE DUODENAL SWITCH (SADI-S) AND SINGLE ANASTOMOSE GASTRIC BY-PASS (OAGBP).
the percentage of total weight loss (%TWL) of the patients after surgery
Time frame: Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
% of patients with gastroesophageal reflux (acid and bile) after surgery
Time frame: 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Number of deaths in the immediate postoperative period
Time frame: up to day 90 post-intervention
Number of Participants with complications in the immediate postoperative period
Time frame: up to day 90 post-intervention
Ratio of patients with more than 3 loose stools per day
The ratio of patients with more than 3 loose stools per day will be evaluated as pathological. To assess the quality of the bowel movements, the Bristol Stool Form Scale questionnaire will be used. An evaluation of the number of bowel movements and their quality according to the Bristol Stool Form Scale questionnaire will be conducted at 1 year, 3 years, and 5 years after the surgery
Time frame: 1 year, 3 years, 5 years after the surgery
questionnaire of quality of life
The quality of life will be assessed based on the results of the Moorehead-Ardelt II test and the Medical Outcomes Study Short Form-36 questionnaire. The Moorehead-Ardelt II questionnaire includes 6 parameters related to self-esteem, physical activity, social contact, job satisfaction, sexual pleasure, and eating habits. The minimum score is -3 and the maximum is +3. A score of 1.1 to 2 is considered a good result, and anything above 2.1 is considered very good. The SF-36 questionnaire includes 8 parameters such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The minimum score is 0 and the maximum is 100.
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Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery
Number of patients with nutritional deficiencies
The main nutritional deficiencies to be evaluated after OAGB (One Anastomosis Gastric Bypass) and SADIS (Single Anastomosis Duodeno-Ileal Switch) are iron and/or vitamin B12 deficiency anemia, deficiencies in fat-soluble vitamins, calcium, and trace elements. The incidence of nutritional deficiencies will be assessed through routine blood tests at 1 year, 3 years, and 5 years after the surgery
Time frame: 1 year, 3 years, 5 years after SADI-S and OAGBP surgery