Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications (SADI-S 250)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Hospital San Carlos, Madrid
Sponsor:
Information provided by (Responsible Party):
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT01463904
First received: October 31, 2011
Last updated: November 1, 2011
Last verified: October 2011

October 31, 2011
November 1, 2011
April 2007
July 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01463904 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Samples of subcutaneous and visceral fat, and samples of liver tissue.

Non-Probability Sample

Morbid obesity patients and patients with obesity and T2DM

  • Morbid Obesity
  • Diabetes
Procedure: SADI-S 250
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy
Morbid obese, diabetics
Patients with morbid obesity or severe metabolic disease
Intervention: Procedure: SADI-S 250
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
April 2015
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 30 with T2DM or BMI > 40

Exclusion Criteria:

  • Oncologic patients, alcoholic patients, mentally retarded
Both
18 Years to 75 Years
Yes
Spain
 
NCT01463904
FMMA-08 Sánchez-Pernaute
No
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
Hospital San Carlos, Madrid
Not Provided
Not Provided
Hospital San Carlos, Madrid
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP