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临床试验/NCT01685177
NCT01685177Unknown不适用

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

Hospital San Carlos, Madrid1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Morbid obesity with initial BMI over 50 submitted to Sleeve Gastrectomy more than 18 months earlier. Excess weight loss with the sleeve under 50%.

排除标准

  • Mental retard, alcoholism, age over 60, concomitant neoplastic disease.

结局指标

主要结局

Weight loss

时间窗: 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.

次要结局

  • Postoperative complications and nutritional complications(First 2 postoperative years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Sanchez-Pernaute

Chief, Esophago-Gastric and Morbid Obesity Surgery Unit

Hospital San Carlos, Madrid

研究点 (1)

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