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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Morbid Obesity

Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SADI<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation. | 5 years from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications and nutritional complications | Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed. | First 2 postoperative years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Sleeve gastrectomy, Duodenal Switch, SADI-S