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

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Unknown status
CT.gov ID
NCT01463904
Collaborator
(none)
250
Enrollment
1
Location
96
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: SADI-S 250

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
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
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Morbid obese, diabetics

Patients with morbid obesity or severe metabolic disease

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • BMI > 30 with T2DM or BMI > 40
    Exclusion Criteria:
    • Oncologic patients, alcoholic patients, mentally retarded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clínico San Carlos Madrid Spain 28040

    Sponsors and Collaborators

    • Hospital San Carlos, Madrid

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, Madrid
    ClinicalTrials.gov Identifier:
    NCT01463904
    Other Study ID Numbers:
    • FMMA-08 Sánchez-Pernaute
    First Posted:
    Nov 2, 2011
    Last Update Posted:
    Nov 2, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, Madrid
    Morbid obesity
    duodenal switch
    diabetes
    decrease in cardiac risk
    remission of T2DM
    Additional relevant MeSH terms:
    Obesity
    Obesity, Morbid

    Study Results

    No Results Posted as of Nov 2, 2011