Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Morbidly Obese Patients: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Excess weight loss at 3 years
研究概览
简要总结
Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.
详细描述
No consensus is proposed by the Medical and Surgical societies to define and / or prioritize surgical procedures in obesity surgery. Indications are based on patient's age, sex, dietary habits, the importance of overweight and associated comorbidities and even if rarely admitted, based on knowledge of surgical teams and the cost of interventions. Given the decrease of gastric banding procedures, Roux-en-Y gastro-jejunal bypass is often considered the reference procedure.
The gastric bypass, developed in the 60s, is performed laparoscopically since the early 90s. It allows for a 60% to 70% excess weight loss with control over 75% of comorbidities. It is recommended to follow these patients long-term because late complications can occur. These patients require ongoing information and regular monitoring. They must also have a hyper-protein diet and a vitamin substitute long-term (multivitamins, vitamin B12, calcium ...).
The Sleeve gastrectomy (SG) arises as an alternative to RYGB. It was classically proposed to patients with a BMI greater than 60 and significant comorbidities since the procedure let to a significant weight reduction in patients for whom any other procedure was too difficult to perform. The quality of the weight loss achieved in these patients has led many teams to analyze the results of this intervention without conducting an additional procedure. It appears from the literature that even performed alone, SG presents many benefits.
To clarify the role of sleeve gastrectomy in the bariatric procedures range, the investigators propose to conduct a prospective randomized study to compare laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass.
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
- •BMI >40 and < 60 kg/m2
- •No contraindication to any of the procedures
- •No contraindication to general anesthesia
- •No known addiction
- •Patient able to provide informed consent
排除标准
- •Contraindication to general anesthesia
- •Known psychiatric pathology
- •Pregnancy
- •Previous major digestive surgery
- •Immunosuppressive treatment including corticoids
- •Coagulopathy (INR>1.5) or platelets < 50 000/µl
- •Anemia (Hb<10g/dl)
- •Severe comorbidity
- •Malabsorptive disease or gastro-intestinal disease
- •Myocardial infarction in previous year, angina, cardiac failure
研究组 & 干预措施
Sleeve gastrectomy
Laparoscopic sleeve gastrectomy
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass
干预措施: Laparoscopic Roux-en-Y gastric bypass (Procedure)
结局指标
主要结局
Excess weight loss at 3 years
时间窗: At 36 months
% of excess weight loss
Change in excess weight loss
时间窗: At 1, 3, 6, 12, months and every year for 10 years
% of excess weight loss
次要结局
- Pain (visual analog scale)(At 1, 3, 6, 12, 18, 24, 30 and 36 months)
- Quality of life (Moorehead-Ardelt II, Gastro-intestinal Quality of Life Index (GIQLI))(At 1, 3, 6, 12, 18, 24, 30 and 36 months)
- Nutritional status and vitamin deficiency(At 1, 3, 6, 12, 18, 24, 30 and 36 months)
- Glycolipid profile(At 1, 3, 6, 12, 18, 24, 30 and 36 months)