Prospective Randomized Controlled Clinical Study Comparing Two Bariatric Bypass Procedures, Roux-en-Y Gastric Bypass (RYGB) and Omega-Loop Gastric Bypass (OLGB), in Patients With Severe Obesity and Metabolic Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS)
研究概览
简要总结
The aim of this study is to compare the relative clinical outcomes between two variants of gastric bypass [Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)] in metabolic surgery candidates with Body Mass Index (BMI) between 35 and 50. The study will examine the short and medium term effects of each intervention on weight, obesity comorbidities, quality of life and gastroscopy findings.
详细描述
Introduction:
Obesity is a risk factor for Diabetes, Ischemic heart disease, Stroke, and Hypertensive heart disease, which are the 6th, 1st, 2nd, and 10th leading causes of death according to the WHO. Bariatric or Metabolic Surgery is an Efficient and reasonably Safe method for the Treatment of Severe Obesity, Type 2 Diabetes (T2DM) and Metabolic Syndrome (MS).
Existing knowledge:
Metabolic procedures, e.g. Gastric bypass, are more effective in the treatment of T2DM than predominantly "restrictive" procedures, e.g. Gastric Banding. RYGB is one of the most prevalent procedures in the world and Europe. In the USA, RYGB is considered a "golden standard" in bariatric surgery. In the recent decade, a simpler variant of Gastric bypass, i.e. OLGB, has been proposed. Proponents of OLGB argue it has less complications and seems to have higher and more durable effect on weight reduction and T2DM improvement. Opponents of OLGB are concerned that chronic exposure of gastric or esophageal mucosa to bile, as seen in animal experiments and in patients operated for gastric cancer or peptic ulcer disease, pose a severe health risk. So far, this concerns has not been confirmed in OLGB patients. Only one Randomized Controlled Trial (RCT) of these two interventions was performed, concluding OLGB to be simpler and safer with a similar Efficacy 2 years after the surgery.
Need for a trial:
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
- •Severe Obesity: BMI ≥ 40 and ≤ 50 or (BMI ≥ 35 and < 40 and type 2 diabetes or metabolic syndrome)
- •Inadequate results of Attempts to loose weight by Conservative means
- •Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
- •no contraindication for bariatric surgery on psychological assessment
- •no contraindication for general anesthesia
- •consent for both variants of gastric bypass surgery
- •consent to participate in a study with randomized design
排除标准
- •prior bariatric surgery of any kind
- •gravidity or recent (<1 year) labour
- •drug or alcohol abuse
- •symptomatic Gastro Esophageal Reflux Disease (GERD)
- •hiatal hernia, > 3cm
- •esophagitis, ≥
- •active smoker
- •chronic renal disease, stage ≥ 3
- •patient immobility
- •surgery not covered by universal insurance in Czech rep. (i.e. international patients)
结局指标
主要结局
Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS)
时间窗: baseline, 1 and 2 years
BAROS composite score rates weight loss, change in comorbidities, and quality of life.
次要结局
- Change in weight, measured as Percent of Excess Weight Loss (%EWL)(baseline, 1 and 2 years)
- Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL)(baseline, 1 and 2 years)
- Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued(baseline, 1 and 2 years)
- Change in Type 2 Diabetes Mellitus, measured as intensity of treatment: diet alone, oral antidiabetic agent(s), insulin (IU/day)(baseline, 1 and 2 years)
- Durability of change in Type 2 Diabetes Mellitus, measured as proportion of patients with T2DM partial remission who experience T2DM "relapse"(2 years)
- Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued(baseline, 1 and 2 years)
- Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued(baseline, 1 and 2 years)
- Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device(baseline, 1 and 2 years)
- Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale(baseline, 1 and 2 years)
- Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as proportion of patients with abnormal finding in each arm(1 and 2 years)
- Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as Rate of unique Event per 100 patient-years of follow up(up to 5 years)
- Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification(30 days)
- Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes(1 and 2 years)
- Incidence of Reoperations, Complications, and detected adverse outcomes, measured as Rate of Event per 100 patient-years of follow up(up to 5 years)
- Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II(baseline, 1 and 2 years)
研究者
Dr. Michal Cierny, PhD
bariatric surgeon
Nemocnice Břeclav, p.o.