Efficacy of Sleeve Gastrectomy, MGB, SASI Bypass in Type 2 Diabetes Obese Patients, Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 主要终点
- excess weight loss
研究概览
简要总结
the investigator Randomized and compare the efficacy of 3 types of metabolic surgery in the treatment of type 2 diabetes in obese patients, one of them is SASI bypass which is a modification of Santoro's operation by performing a loop rather than Roux-en-Y bipartition reconstruction and the investigator are reporting the first comparative clinical trial as regards the clinical results of the outcomes of SASI bypass as a mode of functional restrictive and neuroendocrine modulation therapeutic option for obese type 2 diabetes.
详细描述
from 2011 to 2017, investigators Randomized and collect data for the 3 operations SASI bypass , Mini gastric bypass and Sleeve gastrectomy ) about thorough history, clinical examination and laboratory investigations including basic preoperative investigations, lipid profile, thyroid and suprarenal hormonal evaluation. In addition, patients may undergo further assessment for pulmonary functions or gastroesophageal disease including endoscope. . Abdominal ultrasound was done to exclude gall stones and to evaluate the degree of fatty liver. Reduction the size of fatty liver was done by putting all patients on low-calorie protein diet for 6 weeks. Deep vein thrombosis prophylaxis started 12 h before surgery with low molecular weight heparin subcutaneous injections . Preoperative data included age, gender, initial weight, initial body mass index (BMI), obesity complications and treatment medications used (chest problems, diabetes, arterial hypertension and cardiac ischaemia, hyperlipidemia, obstructive sleep apnea syndrome, gall stones, urinary stress incontinence, joint pain, depression, infertility and heart burn). Postoperative data included hospital stay, early postoperative complications during the first month (e.g. fever, collection, bleeding, vomiting, leak and port site problems .Long-term complications more than 1 month after surgery (e.g. nausea, vomiting, reflux, stricture, intestinal obstruction , hypoalbuminemia , anemia and calcium or iron or vitamin D , vitamin B12 deficiency and), excess weight loss and BMI were collected.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic obese patients
排除标准
- •patients age above 65 or below 18 years old
- •history of upper laparotomy
- •unfit for anesthesia or laparoscopy
- •major psychological instability
- •drug abuse
结局指标
主要结局
excess weight loss
时间窗: one year
The percent of excess weight loss was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.
次要结局
- Resolution of diabetes(one year)
研究者
tarek mahdy
professor of Bariatric and Metabolic surgery
Mansoura University
