A Comparative Study Between Sleeve Gastrectomy and Combined Sleeve Gastrectomy With Loop Bipartition (Short-term Outcomes).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Comparison between sleeve gastrectomy and combined sleeve gastrectomy with loop bipartition (short-term outcomes).
研究概览
简要总结
Aim of the study is To compare short-term outcomes of sleeve gastrectomy operation with those of combined sleeve gastrectomy and loop bipartition procedure.
详细描述
Bariatric surgery has been shown to be the most effective and durable treatment for morbid obesity. Surgery results in significant weight loss and helps prevent, improve or resolve more than 40 obesity-related diseases or conditions including type 2 diabetes, heart disease, obstructive sleep apnea and certain cancers.
Surgery results in greater improvement in weight loss outcomes and obesity-related co-morbidities when compared with non-surgical interventions, regardless of the type of surgical procedure used. The most impressive change in bariatric procedure is the advent of laparoscopic sleeve gastrectomy (LSG). Since 2014, LSG has become the leading bariatric procedure in the USA.
Sleeve gastrectomy with loop bipartition ( SG+LB) was derived from the combined concepts of sleeve gastrectomy with transit bipartition (SG+TB), single anastomosis duodenal-ileostomy (SADI), mini-gastric bypass (MGB) and duodenal-jejunal bypass (DJB) with less nutritional and surgical complications.
Transit bipartition with sleeve gastrectomy (TB-SG) has been getting increased acceptance due to the advantage of preservation of the normal physiology and anatomy of duodenum. In iloe-duodenal sleeve bypass ,patients have a bypassed duodenum which is important in eliminating the foregut's negative incretin effects on insulin; however, this prevents any biliary access, if required later. TB-SG overcomes this problem by preserving the normal duodenal access, which makes the procedure more physiologic and easier to perform. With time, the gastroileal anastomosis has a tendency to enlarge resulting in "functional bypass" of duodenum, enhancing the anti-diabetic effect of the procedure.
- FIRSTLY,Sleeve gastrectomy technique:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose body mass index (BMI) exceeds
- •Patients with BMIs between 35 and 40 with high-risk co-morbid conditions or lifestyle-limiting obesity-induced physical conditions.
- •Age between 18 and 60 years old.
- •Both sexes.
排除标准
- •Patients younger than 18 and older than 60 years old.
- •Obesity due to medical diseases as hypothyroidism, cushing's , ......etc.
- •Surgically-unfit patients as those with contraindications to general anesthesia or uncorrectable coagulopathy.
- •Patients with limited life expectancy due to irreversible cardiopulmonary or other end-organ failure or metastatic or in-operable malignancy.
- •Patients who are pregnant or who expect to be pregnant within 12 months.
结局指标
主要结局
Comparison between sleeve gastrectomy and combined sleeve gastrectomy with loop bipartition (short-term outcomes).
时间窗: one year
Analysis of the effects of both stand-alone sleeve gastrectomy procedure and combined sleeve gastrectomy with loop bipartition on weight loss and obesity-related hypertension and diabetes mellitus, and also the complications associated with each procedure .
次要结局
未报告次要终点
研究者
Ahmed Abdou Gad Youssef
doctor
Assiut University