Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastr... | NCT01463904

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

NCT01463904

Sponsor

Hospital San Carlos, Madrid

Status

Unknown status

Last Update Posted

Nov 2, 2011Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Morbid Obesity
Diabetes

Interventions

SADI-S 250

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Apr 2015Estimated

First Submitted Date

Oct 31, 2011

First Submission Date that Met QC Criteria

Nov 1, 2011

First Posted Date

Nov 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2011

Last Update Posted Date

Nov 2, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, MadridPrincipal Investigator

Lead Sponsor

Hospital San Carlos, MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morbid obese, diabetics		Patients with morbid obesity or severe metabolic disease	Procedure: SADI-S 250

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SADI-S 250	Procedure	Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy	Morbid obese, diabetics

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI > 30 with T2DM or BMI > 40

Exclusion Criteria:

Oncologic patients, alcoholic patients, mentally retarded

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Morbid obesity patients and patients with obesity and T2DM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínico San Carlos	Recruiting	Madrid	Madrid	28040	Spain

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided