Single Anastomosis Sleeve Jejunal Bypass Versus One Anastomosis Gastric Bypass in Management of Morbid Obese Patients: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Weight loss parameters
研究概览
简要总结
This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation.
详细描述
This study is going to be prospectively randomized. There will be one hundred people with morbid obesity undergoing bariatric surgery at the hospitals of Sohag University and Ainshams University. The investigator will select which individuals will have gastric bypass surgery after counseling patients about all bariatric procedures. The patients were randomly assigned to two equal groups (50 per group); the first patient was OAGB (group A), and the second was SASJ (group B). After the study has been approved by the ethics council of the Sohag University and Ain shams university, Faculty of Medicine, all patients must give written informed consent for participation.
the investigators included a total of 100 cases in this prospective randomized study, and they were divided into two equal groups; SASJ and OAGB groups. The two procedures were performed by the same surgical team adapting standardized techniques. Weight loss parameters were our primary objectives, while secondary outcomes included operative time ,post-operative complications, nutritional(macro and micro nutrients) status, improvement/resolution of comorbidities and quality of life.
Total number of 100 patients, aged between 16 and 60 years, with BMI > 40 kg/m2, or BMI > 35 kg/m2 with the presence of obesity related comorbidity (diabetes mellitus, hypertension, OSAS, osteoarthritis) were enrolled in this study.
An informed written consent was signed by all patients, after complete explanation of the idea of the study, along with the benefits and drawbacks of each procedure. Detailed history taking, physical examination, routine preoperative laboratory investigations and abdominal ultrasonography were performed for all cases.
The 100 cases were randomly allocated into two equal groups SASJ and OAGB groups. Randomization was done in the operating room . All cases were performed by laparoscopy under general anesthesia. The two procedures were performed by 5 ports, .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index of over 35 plus the comorbidity presence.
- •body mass index of over 40 with/without comorbidity.
- •patients' willingness to participate in the study.
- •patients' cooperation in follow-up researches.
- •lacking any psychiatric disease.
排除标准
- •Patients negating to change their lifestyle.
- •drug abuse and/or addiction.
- •eating disorder background (e.g., bulimia nervosa).
- •Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
- •pregnant patients.
- •previous upper abdominal procedures,
- •reflux symptoms
- •major unstable psychiatric illness.
研究组 & 干预措施
single anastomosis sleeve jejunal bypass group
干预措施: single anastomosis sleeve jejunal bypass (Procedure)
one anastomosis gastric bypass
dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ grou p.
干预措施: One anastomosis gastric bypass (Procedure)
结局指标
主要结局
Weight loss parameters
时间窗: 2 years
次要结局
未报告次要终点
研究者
Ashraf Gamal Abdelraoof
assistant lecturer of general surgery at sohag university hospitals
Sohag University