Evaluation on Common Limb Length in Laparoscopic One-anastomosis Gastric Bypass for Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- the percentage of excess weight loss
研究概览
简要总结
Evaluation of the effect of the common limb length on the outcome of laparoscopic single anastomosis gastric bypass in morbidly obese patients.
Two groups of patients: one group with a common limb length of about 200 cm distal to the ligament of Treitz and the second group with a common limb length of 300 cm proximal to the ileocecal valve.
Groups are evaluated regarding percentage of excess weight loss, resolution of comorbidities, and long term complications.
详细描述
The present study is a prospective, randomized comparative clinical trial involving 60 patients (due to limited flow rate and high expenses [14]) who will be subjected to laparoscopic single anastomosis gastric bypass at the department of surgery, Mansoura university, Mansoura, Egypt at the period from May 2016 to May 2019.
Patients will be randomly allocated into 2 groups with 30 patients undergoing LSAGB with measuring two meters from the duodenojejunal junction, and the other 30 undergoing LSAGB with measuring three meters from the ileocecal valve.
Informed consent will be obtained from all patients participating in the study after explaining the patients about the benefits and the potential risks involved.
Inclusion criteria:
- Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis).
- Age between 18 and 60 years old.
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
- •Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis).
- •Age between 18 and 60 years old.
排除标准
- •Pregnancy or desire to be pregnant during the study.
- •Abnormal findings on upper GI endoscopy.
- •Presence of chronic diarrhea (≥ 3 liquid or loose stools per day, over a period of more than 4 weeks).
- •Obesity due to organic disease e.g, cushing disease and hypothyroidism.
- •Previous bariatric surgery.
- •Coexisting severe hepatic, pulmonary, renal, cardiovascular, neurological and psychiatric diseases.
结局指标
主要结局
the percentage of excess weight loss
时间窗: 2 years
the percentage of total body weight loss
时间窗: 2 years
resolution or improvement of comorbidities
时间窗: 2 years
cessation of treatment or reduction of medications
次要结局
- early postoperative morbidities(3 months)
- late complications(2 years)
研究者
Hosam Hamed
Lecturer of general surgery
Mansoura University