Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Prospective Study Comparing 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)

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Procedure: metabolic surgery (SADIS and OAGB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 and under 65 who meet criteria for bariatric surgery. Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time Signature of the informed consent of the study Patients suitable for laparoscopic surgery Exclusion Criteria: Previous bariatric surgery 2-stage surgery Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery Other associated surgical procedures in the same intervention. Conversion to laparotomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: SADI-S<br>SINGLE ANASTOMOSE DUODENAL SWITCH | Procedure: metabolic surgery (SADIS and OAGB)<br>* 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).<br>|
| Active Comparator: Group B: OAGB<br>SINGLE ANASTOMOSE GASTRIC BY-PASS | Procedure: metabolic surgery (SADIS and OAGB)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of total weight loss (%TWL) of the patients after surgery |  | Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with gastroesophageal reflux (acid and bile) after surgery |  | 1 year, 3 year, 5 year after SADI-S and OAGBP surgery | 
| Number of deaths in the immediate postoperative period |  | up to day 90 post-intervention | 
| Number of Participants with complications in the immediate postoperative period |  | 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 | 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. | 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 | 1 year, 3 years, 5 years after SADI-S and OAGBP surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAGB, SADIS, bariatric surgery