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

Obesity, Morbid Clinical Trial

— OASIS  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948852
• Other study ID #: 23/001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2029

Study information

• Verified date: July 2023
• Source: Consorci Sanitari Integral
• Contact: Sergio Sanchez Cordero, MD
• Phone: +34 93 553 12 00
• Email: Sergi.SanchezCordero[@]sanitatintegral.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 2029
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	% of patients with gastroesophageal reflux (acid and bile) after surgery		1 year, 3 year, 5 year after SADI-S and OAGBP surgery
Secondary	Number of deaths in the immediate postoperative period		up to day 90 post-intervention
Secondary	Number of Participants with complications in the immediate postoperative period		up to day 90 post-intervention
Secondary	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
Secondary	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
Secondary	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