Randomized Clinical Trial on the Outcome of Gastric Bypass With Biliopancreatic and Alimentary Limbs of 150 Centimeters (cm)/70 cm Versus(vs) 70/150 cm, Measuring the Length of the Common Limb
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Excess Weight Loss (%EWL)
研究概览
简要总结
Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. However, more than 25% of patients do not obtain the expected result.
There is no uniform technique to perform a LRYGB, but traditionally it was constructed using a long alimentary limb (AL) and a short biliopancreatic limb (BPL). There is no current consensus on the ideal length of the LRYGB limbs.
The distal gastric bypass at the expense of a longer biliopancreatic limb (LBPL-GB) could induce more excess of weight loss (EWL%), but with possible protein malnutrition depending on the length of the remaining common limb.
The aim of this study is compare a LBPL-GB (BPL 150cm, AL 70cm) with LAL-GB (BPL 70cm, AL 150cm).
PRIMARY OUTCOME: to evaluate if there are differences in weight loss. SECONDARY OUTCOME: to assess whether there are differences in both groups in remission of the most common comorbidities and in quality of life.
DESIGN: multicenter, prospective, randomized study in blocks (1:1), blinded for the patient and to the surgeon up to the time of intervention, in patients with indication of RYGB for obesity (BMI>35 with associated comorbidity or BMI>40 with or without comorbidity, excluding those of BMI>50). Intervention: LRYGB type 1 (LAL-GB: 150cm ALand 70cm BPL) or type 2 (LBPL-GB: 70cm AL and 150cm BPL).
The expected result is that the patients with LBPL-GB present better EWL%, and higher remission of their comorbidities than the comparison group
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
- Single (Participant)
盲法说明
Blinded for the patient and to the surgeon up to the time of intervention
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with BMI 35-40 kg/m2 with associated medical problems (Diabetes Mellitus, Hipertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome) or 40-50 kg/m2 with or without associated medical problems, who comply with the regulatory rules for bariatric surgery in Spain (SECO and AEC)
排除标准
- •General contraindications to kind of surgery
- •BMI > 50 kg/m2
- •Known drug or alcohol abuse
- •ASA (American Society of Anesthesiology) physical status classification > III
- •Inability to follow the procedures of the study
结局指标
主要结局
Excess Weight Loss (%EWL)
时间窗: From baseline to five years after surgery
The Excess Weight Loss (%EWL) after surgery. (Preoperatory weight in kilograms - current weight in kilograms) / (preoperatory weight in kilograms) x 100
次要结局
- Remission or improvement of Type 2 Diabetes Mellitus(From baseline to five years after surgery)
- Remission or improvement of Obstructive Sleep Apnea Syndrome(From baseline to five years after surgery)
- Remission of improvement of Dyslipidemia(From baseline to five years after surgery)
- Remission or improvement of Hypertension(From baseline to five years after surgery)
研究者
Débora Acín
MD, PhD, Bariatric Surgeon
Hospital Universitario de Fuenlabrada