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

Consorci Sanitari Integral

Status: Not yet enrolling

Conditions: Obesity, Morbid

Treatments: Procedure: metabolic surgery (SADIS and OAGB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05948852

23/001

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Group A: SADI-S

Experimental group

Description:

SINGLE ANASTOMOSE DUODENAL SWITCH

Treatment:

Procedure: metabolic surgery (SADIS and OAGB)

Group B: OAGB

Active Comparator group

Description:

SINGLE ANASTOMOSE GASTRIC BY-PASS

Treatment:

Procedure: metabolic surgery (SADIS and OAGB)