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

• Conditions: Morbid Obesity

• Registration Number: NCT01685177
• Lead Sponsor: Hospital San Carlos, Madrid

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.

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 Timeline

• Study Start: 2009-09
• Status Verified: 2012-09
• Study First Submitted: 2012-09-09
• Study First Submitted QC: 2012-09-11
• Last Update Submitted: 2012-09-11
• Study First Posted: 2012-09-14
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain