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

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)

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 Overview

• Status: Not yet recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: metabolic surgery (SADIS and OAGB)

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Sanchez Cordero, MD; Phone Number: 8902 +34 93 553 12 00; Email: Sergi.SanchezCordero@sanitatintegral.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Consorci Sanitari Integral

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: bariatric surgery; OAGB; SADIS
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 23/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No