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 recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hospital San Carlos, Madrid.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014