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 because the information has not been verified recently.
Verified October 2011 by Hospital San Carlos, Madrid.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
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.
Procedure: SADI-S 250
||Observational Model: Cohort
Time Perspective: Prospective
||Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Biospecimen Retention: Samples With DNA
Samples of subcutaneous and visceral fat, and samples of liver tissue.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||July 2009 (Final data collection date for primary outcome measure)
Morbid obese, diabetics
Patients with morbid obesity or severe metabolic disease
Procedure: SADI-S 250
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy
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)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Morbid obesity patients and patients with obesity and T2DM
- BMI > 30 with T2DM or BMI > 40
- Oncologic patients, alcoholic patients, mentally retarded
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01463904
|Hospital Clínico San Carlos
|Madrid, Spain, 28040 |
|Contact: Andrés Sánchez-Pernaute, MD PhD +3413303184 firstname.lastname@example.org |
|Principal Investigator: Andrés Sánchez-Pernaute, MD PhD |
Hospital San Carlos, Madrid
||Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, Madrid
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 31, 2011
||November 1, 2011
||Spain: Comité Ético de Investigación Clínica
Keywords provided by Hospital San Carlos, Madrid:
decrease in cardiac risk
remission of T2DM
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2016
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