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

• Sponsor: Consorci Sanitari Integral (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05948852
• Collaborator: (none)
• Enrollment: 96
• Arms: 2
• Anticipated Duration (Months): 72

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Procedure: metabolic surgery (SADIS and OAGB)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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)
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: SADI-S SINGLE ANASTOMOSE DUODENAL SWITCH	Procedure: metabolic surgery (SADIS and OAGB); 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).
Active Comparator: Group B: OAGB SINGLE ANASTOMOSE GASTRIC BY-PASS	Procedure: metabolic surgery (SADIS and OAGB); 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 Outcome Measures

1. 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

1. % of patients with gastroesophageal reflux (acid and bile) after surgery [1 year, 3 year, 5 year after SADI-S and OAGBP surgery]

2. Number of deaths in the immediate postoperative period [up to day 90 post-intervention]

3. Number of Participants with complications in the immediate postoperative period [up to day 90 post-intervention]

4. 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

5. 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.

6. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Consorci Sanitari Integral

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consorci Sanitari Integral
• ClinicalTrials.gov Identifier: NCT05948852
• Other Study ID Numbers: 23/001
• First Posted: Jul 17, 2023
• Last Update Posted: Jul 17, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Consorci Sanitari Integral: OAGB; SADIS; bariatric surgery
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Jul 17, 2023