Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications

• Conditions: Morbid Obesity; Diabetes
• Interventions: Procedure: SADI-S 250

• Registration Number: NCT01463904
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of T2DM. A lower complication rate than for duodenal switch is expected.

Detailed Description

A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum.

The preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-07
• Status Verified: 2011-10
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-01
• Last Update Submitted: 2011-11-01
• Study First Posted: 2011-11-02
• Last Update Posted: 2011-11-02
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• BMI > 30 with T2DM or BMI > 40

Exclusion Criteria

• Oncologic patients, alcoholic patients, mentally retarded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Morbid obese, diabetics	SADI-S 250	Patients with morbid obesity or severe metabolic disease

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain