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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Hospital San Carlos, Madrid.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid Identifier:
First received: October 31, 2011
Last updated: November 1, 2011
Last verified: October 2011
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.

Condition Intervention
Morbid Obesity
Procedure: SADI-S 250

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications

Further study details as provided by Hospital San Carlos, Madrid:

Biospecimen Retention:   Samples With DNA
Samples of subcutaneous and visceral fat, and samples of liver tissue.

Estimated Enrollment: 250
Study Start Date: April 2007
Estimated Study Completion Date: April 2015
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Morbid obese, diabetics
Patients with morbid obesity or severe metabolic disease
Procedure: SADI-S 250
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Morbid obesity patients and patients with obesity and T2DM

Inclusion Criteria:

  • BMI > 30 with T2DM or BMI > 40

Exclusion Criteria:

  • Oncologic patients, alcoholic patients, mentally retarded
  Contacts and Locations
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Please refer to this study by its identifier: NCT01463904

Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Andrés Sánchez-Pernaute, MD PhD    +3413303184   
Principal Investigator: Andrés Sánchez-Pernaute, MD PhD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
  More Information

Responsible Party: Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, Madrid Identifier: NCT01463904     History of Changes
Other Study ID Numbers: FMMA-08 Sánchez-Pernaute
Study First Received: October 31, 2011
Last Updated: November 1, 2011

Keywords provided by Hospital San Carlos, Madrid:
Morbid obesity
duodenal switch
decrease in cardiac risk
remission of T2DM

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017