Prospective Comparative Study Evaluating the Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SAS-J) VS Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The aim of this work is to compare the outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) with sleeve gastrectomy as regards efficacy including sustained weight loss, metabolic syndrome, quality of life, complications and associated comorbidities in morbid obese.
详细描述
The most commonly performed bariatric surgery worldwide is the vertical sleeve gastrectomy (VSG), the Roux-en-Y gastric bypass (RYGB), and the One anastomosis (Mini) gastric bypass, which has been demonstrated to produce excellent bariatric and metabolic outcomes.
Single anastomosis sleeve ileal (SASI) bypass was introduced in 2015 as a modification of Santorini's operation in, as it keeps pass to the duodenum so the biliary tree and the whole gut and can be assessed by the endoscope; there are no blind loops, excluded segments or foreign bodies.
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
- 否
入选标准
- •Patients age from 18 to 60 years old.
- •Both sexes.
- •Patients with body mass index (BMI) ≥
- •Patients with BMI (35 - 40) with obesity related comorbidities. (e.g. type 2 diabetes mellitus, obstructive sleep apnea, hypertension, hyperlipidemia, obesity hypoventilation syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux disease and severe arthritis).
- •Able to be committed to follow-up.
排除标准
- •Patients underwent previous Bariatric surgeries.
- •Patients with severe systemic disease, such as congestive heart failure - unstable angina - recent stroke or myocardial infarction less than 3 months ago. Contraindications for insufflation as those with severe cardiovascular or severe restrictive respiratory diseases.
- •Patients that refused to participate in the study.
- •Patients with psychiatric illness.
- •Preoperative upper GI endoscopy findings of GERD class C and Barrett's oesophagus
- •Previous upper GIT surgery or liver cirrhosis.
- •Patients on oral steroid therapy.
- •Not fit for general anaesthesia (e.g. patients with severe heart disease or untreatable coagulopathies).
- •Significant abdominal adhesions.
- •Major psychiatric illness.
- •Pregnant patients.
研究组 & 干预措施
Group (A) (SASJ Group)
Patients underwent single anastomosis sleeve jejunal bypass as a metabolic and weight loss surgery.
干预措施: Single anastomosis sleeve jejunal bypass (Procedure)
Group (B) (Lap Gastric Sleeve Group)
Patients underwent laparoscopic sleeve gastrectomy(LGS) as a metabolic and weight loss surgery.
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
结局指标
主要结局
Weight loss
时间窗: 1 month after the procedure
Weight loss was recorded.
次要结局
- Metabolic syndrome(1 month after the procedure)
- Assessment of quality of life(1 month after the procedure)
- Incidence of complications(1 month after the procedure)
研究者
Riham AbdelNasser gad sayed
Assistant Lecturer in General Surgery, Ain Shams University, Cairo, Egypt.
Ain Shams University