Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

Aleris Hospital

Status: Active, not recruiting

Conditions: Postoperative Complications; Bariatric Surgery Candidate; Metabolic Syndrome; Obesity, Morbid

Treatments: Procedure: SASI Bipartition; Procedure: Gastric bypass

Study type: Observational

Funder types: Other

Identifiers

NCT04469712

66095

Details and patient eligibility

About

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

Full description

The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary.

Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery.

Results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)

Exclusion criteria

• Mental diseases
• Drug addiction
• Alcoholic
• Malignancy
• Pregnancy

Trial design

280 participants in 2 patient groups

SASI Bipartition

Description:

Subjects submitted to SASI Bipartition

Treatment:

Procedure: SASI Bipartition

Roux-en-Y gastric bypass

Description:

Subjects submitted to gastric bypass

Treatment:

Procedure: Gastric bypass