SADI vs CD: Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Weight loss [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
- Postoperative complications and nutritional complications [First 2 postoperative years]
Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Hospital San Carlos, Madrid
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Sánchez-Pernaute A, Herrera MA, Pérez-Aguirre ME, Talavera P, Cabrerizo L, Matía P, Díez-Valladares L, Barabash A, Martín-Antona E, García-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
- Sánchez-Pernaute A, Rubio Herrera MA, Pérez-Aguirre E, García Pérez JC, Cabrerizo L, Díez Valladares L, Fernández C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. Epub 2007 Nov 27.
- SADI-CD