跳至主要内容
临床试验/NCT04218045
NCT04218045Unknown不适用

Laparoscopic Single Anastomosis Sleeve Ileal (SASI) Bypass Versus Laparoscopic Sleeve Gastrectomy For Morbidly Obese Patients

Zagazig University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
2
主要终点
operative time

研究概览

简要总结

Evaluation of the advantages, disadvantages and complications of a recently innovated procedure (Single anastomosis sleeve ileal "SASI" bypass) of the more traditional laparoscopic sleeve gastrectomy "LSG"

详细描述

Obesity is a major health problem affecting over 1.7 billion people. Obesity is defined as excess body weight due to abnormal or excessive fat accumulation that presents a risk to health. A crude popular measure of obesity is the body mass index (BMI), a person's weight (in kilograms) divided by the square of his or her height (in meters). A person with a BMI of 30 or more is generally considered obese. A person with a BMI equal to or more than 25 is considered overweight.

Obesity is a major risk factor for a number of chronic diseases, including diabetes mellitus, cardiovascular diseases and cancer. It is associated with significant co-morbid conditions and reduced life expectancy. Since 1997, obesity has been officially recognized by the World Health Organization as a global epidemic.

Bariatric surgery has been shown to be the most successful approach in managing morbid obesity that can achieve and sustain great weight loss for a long period.

Common strategies of bariatric surgery are: mechanical obstacles to food ingestion, nutrient-excluded segments and malabsorption, which are a potential cause for complications and should better be avoided from a strictly physiological prospect. Also, such procedures necessitate lifelong medical supervision with the supplementation of vitamins and nutrients. Moreover, they are frequently associated with dysphagia and vomiting as a result of anatomical restrictions.

Laparoscopic sleeve gastrectomy (LSG) was initially established as the first stage of a two stage bariatric approach. It is now used as a primary bariatric procedure because of documented excellent weight loss and an acceptable risk of complication. Advantages include the avoidance of implantable material, maintenance of gastrointestinal continuity, avoidance of malabsorption, and convertibility to other operations. However, The major disadvantage of LSG is the severity of the major postoperative complications like bleeding and staple-line leakage. Staple-line disruption is the most life-threatening complication after LSG, Leaks after sleeve gastrectomy (SG) mostly occur because of the creation of a high internal pressure pouch.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Masking cannot be applied as both patient and surgeons must be fully informed and consenting regarding the procedure of choice, and the possible outcomes and complications

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 (BMI ≥ 40 kg/m2) or ( ≥ 35 kg/m2 with associated co-morbidity e.g. type 2 diabetes, joint problems ...)
  • Age ≥ 18 and < 60
  • Failure to achieve adequate and consistent weight loss for at least one year while being followed up by a dietitian.

排除标准

  • Patients BMI < 35kg/m2
  • Patients who managed to achieve consistent weight loss by diet control.
  • Contra-indications to laparoscopic surgery e.g. intolerance to general anesthesia, coagulopathy or an associated condition that requires laparotomy.
  • Contra-indications to gastrectomy e.g. gastric ulcer, hiatal hernia or gastro-esophageal reflux disease.
  • Previous laparotomy or bariatric procedure.

结局指标

主要结局

operative time

时间窗: the day of operation only

duration of operation by each technique (in minutes)

intra-operative complications

时间窗: the day of operation only

incidence of intra-operative adverse events e.g. bleeding, visceral injury

Post-operative complications

时间窗: within 12 weeks of the operation

incidence of post operative complications (Most importantly leakage) other complications e.g. bleeding, thrombo-embolism, chest complications, wound infection...

Percentage of Excess Weight Loss (%EWL)

时间窗: within 1 year of the operation

Percentage of weight loss during the year after operation, calculated as a percentage of the excess weight estimated before operation (in kilograms)

次要结局

  • change in co-morbidities(within one year of the operation)
  • incidence of anemia, protein or vitamin deficiency(within one year of the operation)

研究者

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

yousef ahmed el-ayman

assistant lecturer of general surgery, Master degree, MD Candidate

Zagazig University

研究点 (2)

Loading locations...

相似试验