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)

This study is currently recruiting participants.
Verified September 2012 by Hospital San Carlos, Madrid
Sponsor:
Information provided by (Responsible Party):
Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT01685177
First received: September 9, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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
Morbid Obesity

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
    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:
  • Postoperative complications and nutritional complications [ Time Frame: First 2 postoperative years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 30
Study Start Date: September 2009
Groups/Cohorts
SADI
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

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%.

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685177

Contacts
Contact: Andrés Sánchez-Pernaute, MD PhD +3413303184 pernaute@yahoo.com

Locations
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Andrés Sánchez-Pernaute, PhD MD     +3413303184     pernaute@yahoo.com    
Sponsors and Collaborators
Hospital San Carlos, Madrid
  More Information

Publications:
Responsible Party: Andres Sanchez-Pernaute, Chief, Esophago-Gastric and Morbid Obesity Surgery Unit, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT01685177     History of Changes
Other Study ID Numbers: SADI-CD
Study First Received: September 9, 2012
Last Updated: September 11, 2012
Health Authority: Spain: "Spanish National Health Service"

Keywords provided by Hospital San Carlos, Madrid:
Morbid obesity
Sleeve gastrectomy
Duodenal Switch
SADI-S

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013