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NCT01463904 Clinical Trial

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

Diabetes Clinical Trial

— SADI-S 250  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01463904
Other study ID # FMMA-08 Sánchez-Pernaute
Secondary ID
Status Recruiting
Phase N/A
First received October 31, 2011
Last updated November 1, 2011
Start date April 2007
Est. completion date April 2015

Study information
Verified date October 2011
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date April 2015
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- BMI > 30 with T2DM or BMI > 40

Exclusion Criteria:

- Oncologic patients, alcoholic patients, mentally retarded

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• SADI-S 250
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy

Locations
Country Name City State
Spain Hospital Clínico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

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