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)
| Registry | NCT05948852, acronym OASIS |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 96 (Estimated) |
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| Sponsor | Consorci Sanitari Integral (Other) |
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| Conditions | Obesity, Morbid |
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| Interventions | metabolic surgery (SADIS and OAGB) (Procedure) |
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| Dates | start 2023-07-01 (estimated), primary completion 2024-07-01 (estimated), completion 2029-07-01 (estimated), first posted 2023-07-17, last updated 2023-07-17 |
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All trials for Obesity, Morbid All trials of metabolic surgery (SADIS and OAGB)
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Group A: SADI-S | Experimental | Procedure: metabolic surgery (SADIS and OAGB) | SINGLE ANASTOMOSE DUODENAL SWITCH |
| Group B: OAGB | Active comparator | Procedure: metabolic surgery (SADIS and OAGB) | SINGLE ANASTOMOSE GASTRIC BY-PASS |
- metabolic surgery (SADIS and OAGB) (Procedure): 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).
+Outcome measures
Primary outcomes
- 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 outcomes
- % 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 [1 year, 3 years, 5 years after the surgery]: 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
- questionnaire of quality of life [1 year, 3 years, 5 years after SADI-S and OAGBP surgery]: 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.
- Number of patients with nutritional deficiencies [1 year, 3 years, 5 years after SADI-S and OAGBP surgery]: 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
+Eligibility
Sex: All, ages: 18 Years to 65 Years
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