Single Anastomosis Duodenal Ileal Bypass (SADI) as a Second Stage for Sleeve Gastrectomy Weight Loss Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percent Total Weight Loss (change in weight relative to baseline)
研究概览
简要总结
The goal of this study is two part: 1) to add to the literature which is still somewhat sparse with numbers of patients undergoing the Single Anastomosis Duodenal Ileal Bypass (SADI) as a revision for laparoscopic sleeve gastrectomy (LSG) and 2) to have a treatment option for our Kaiser Permanente patients who seek additional assistance after a LSG with persistent morbid obesity and the comorbidities that come with it.
详细描述
Patients will be recruited during 10/15/2019 through 04/30/2022 with the following inclusion criteria: 1) body mass index (BMI) 35 - 39 kg/m2 with comorbid conditions; 2) BMI 40+ kg/m2 with no comorbidities; 3) having a previous LGS; 4) having lost less than 10% total weight loss with this LSG; 5) being a Kaiser member at the time of surgery; and 6) being at least 18 years of age. Exclusion criteria will include: 1) BMI less than 35; 2) having a hiatal hernia; 3) having severe Gastroesophageal Reflux Disease; 4) having a primary bariatric procedure other than LSG; 5) having already had a revisional bariatric procedure; and 6) being less than 18 years old.
Age range for participants will be 18 - 100 years old. We will recruit 50 patients.
Revisional procedures for weight regain are PART OF USUAL CARE at Kaiser Permanente Southern California. However SADI is a type of revisional procedure that is still considered experimental. This procedure has a single surgical anastomosis. It has a restrictive component when reducing the greater curvature of the stomach, but specially a malabsorptive component, as the common channel is also reduced. The objective of this surgical technique is to lessen the intestinal loop where nutrients are absorbed. It was part of a more extreme procedure, that is currently standard of care, called the Duodenal Switch (DS).
The DS procedure which is PART OF USUAL CARE results in very successful massive weight loss however, it also has severe complications especially vitamin deficiencies. The SADI procedure is thought to confer the same weight loss benefits of the DS but without the severe complications. This has not been tested systematically.
These eligibility criteria will be verified by the bariatric surgeon who is doing the consult for a revisional procedure AS PART OF USUAL CARE. This will entail the surgeon looking in the electronic medical record before meeting with the patient. However, this review of the medical record before surgical consult is PART OF USUAL CARE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) 35 - 39 kg/m2 with comorbid conditions; OR
- •BMI 40+ kg/m2 with no comorbidities; AND
- •having a previous laparoscopic sleeve gastrectomy (LGS); AND
- •having lost less than 10% total weight loss with this LSG; AND
- •being a Kaiser member at the time of surgery; AND
- •being at least 18 years of age.
排除标准
- •BMI less than 35 kg/m2; OR
- •having a hiatal hernia; OR
- •having severe Gastroesophageal Reflux Disease; OR
- •having a primary bariatric procedure other than LSG; OR
- •having already had a revisional bariatric procedure; OR
- •being less than 18 years old.
结局指标
主要结局
Percent Total Weight Loss (change in weight relative to baseline)
时间窗: 3 years
This is weight loss relative to the initial body weight at the time of surgery calculated as (weight at surgery - weight at follow-up)/weight at surgery. This is already a change score.
次要结局
未报告次要终点