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Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient (SADI vs CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685177
Recruitment Status : Unknown
Verified September 2012 by Andres Sanchez-Pernaute, Hospital San Carlos, Madrid.
Recruitment status was:  Recruiting
First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Information provided by (Responsible Party):
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid

Brief Summary:
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.

Condition or disease
Morbid Obesity

Detailed Description:
Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI before surgery (usually over 50 - 55), a second-step operation should be performed to increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.: a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass. And, finally, a subset of patients, generally those with higher initial BMI, are offered a malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not offering a greater weight loss rate, and it is a complex operation requiring sectioning of the sleeve and two anastomoses. We support the performance of malabsorptive operations which warrant a better weight loss result for "resistant" patients needing a second-step. As Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a good primary operation for morbid obesity, we decided to test this one-loop reconstruction as a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal switch performed as a second step after a "failed" sleeve.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Trial Comparing Single-Anastomosis Duodeno-Ileal Bypass With Standard Roux-en-Y Duodenal Switch as a Second Step After a Sleeve Gastrectomy in the Super-Morbid Obese Patient
Study Start Date : September 2009

Patients submitted to a second-step operation after a failed sleeve on which a single-anastomosis duodena-ileal bypass at 250 cm from the cecum is performed.

Primary Outcome Measures :
  1. Weight loss [ Time Frame: 5 years from surgery ]
    Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.

Secondary Outcome Measures :
  1. Postoperative complications and nutritional complications [ Time Frame: First 2 postoperative years ]
    Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed.

Biospecimen Retention:   Samples With DNA
Fat, liver tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attended in the Surgery Clinic with Morbid Obesity submitted to a sleeve gastrectomy and needing a second-step operation.

Inclusion Criteria: Morbid obesity with initial BMI over 50 submitted to Sleeve Gastrectomy more than 18 months earlier. Excess weight loss with the sleeve under 50%.


Exclusion Criteria: Mental retard, alcoholism, age over 60, concomitant neoplastic disease.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685177

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Contact: Andrés Sánchez-Pernaute, MD PhD +3413303184

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

Publications of Results:
Other Publications:
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Responsible Party: Andres Sanchez-Pernaute, Chief, Esophago-Gastric and Morbid Obesity Surgery Unit, Hospital San Carlos, Madrid Identifier: NCT01685177    
Other Study ID Numbers: SADI-CD
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: September 14, 2012
Last Verified: September 2012
Keywords provided by Andres Sanchez-Pernaute, Hospital San Carlos, Madrid:
Morbid obesity
Sleeve gastrectomy
Duodenal Switch
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms