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

NCT ID: NCT01463904

Last Updated: 2011-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Morbid Obesity Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Morbid obese, diabetics

Patients with morbid obesity or severe metabolic disease

SADI-S 250

Intervention Type PROCEDURE

Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy

Interventions

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SADI-S 250

Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30 with T2DM or BMI \> 40

Exclusion Criteria

* Oncologic patients, alcoholic patients, mentally retarded
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Andres Sanchez-Pernaute

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Andrés Sánchez-Pernaute, MD PhD

Role: primary

[email protected]
+3413303184

Other Identifiers

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FMMA-08 Sánchez-Pernaute

Identifier Type: -

Identifier Source: org_study_id