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)
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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 |
|---|
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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 |
- 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.
- 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 |
|---|
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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.
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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 |
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%.
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Exclusion Criteria: Mental retard, alcoholism, age over 60, concomitant neoplastic disease.
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Contacts and Locations| Contact: Andrés Sánchez-Pernaute, MD PhD | +3413303184 | pernaute@yahoo.com |
| Spain | |
| Hospital Clínico San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Andrés Sánchez-Pernaute, PhD MD +3413303184 pernaute@yahoo.com | |
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:
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Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013