Randomized Controlled Non-inferiority Trial Evaluating the Safety and Efficacy of the Omega Gastric Bypass With 150 cm Biliopancreatic Loop Length Compared to the Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).
研究概览
简要总结
Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities . With nearly 50000 procedures per year France ranks third in the world in terms of care for patients suffering from morbid (BMI ≥ 40 kg/m²) and severe (BMI 35-40 kg/m²) obesity.
In parallel with the significant increase in the number of patients operated on for obesity in the world, over the past two decades, significant development has been observed in the field of bariatric surgery with a decrease or even disappearance of some procedures and the appearance of others.
Performed for more than 40 years, the Roux-en-Y Gastric Bypass (RYGB) is a restrictive and malabsorptive procedure and currently is considered as gold standard procedure for the treatment of morbid obesity and its comorbidities. However, despite the good effectiveness (with an average Excess Weight Loss % (EWL%) of approximatively 70% at 2 years), RYGB is technically demanding procedure with learning curve requiring more than 100 cases and an overall complication rate ranging from 10% to 20% Introduced in 2001, one anastomosis gastric bypass (OAGB) is a modified gastric bypass that consists of a single gastrojejunal anastomosis between a long gastric pouch and a jejunal (biliopancreatic) omega loop. In Sept. 2019, taking into account the results from YOMEGA trial, the French High Authority for Health (Haute Autorité de Santé (HAS)) recommended to ban OAGB with 200 cm or longer BPL and urged to assess the efficacy and safety of OAGB with 150 cm BPL in a randomized controlled trial. Indeed, YOMEGA-2 trial is logical continuity of the YOMEGA trial.
The aim of this study is to assess weight loss efficiency and the nutritional safety of the OAGB-150 in comparison to a standard (RYGB).
The hypothesis of this study is that the OAGB with a 150 cm BPL could have the same efficacy on weight loss and nutritional complication rate in comparison to the RYGB at 2 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged from 18 to 65 years old
- •Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
- •Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery
- •Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass
- •Patient who understood and accepted the need for a long-term follow-up
- •Patient who agreed to be included in the study and who signed the informed consent form
- •Patient affiliated to a social security scheme
- •For child-bearing aged women, efficient contraception
排除标准
- •History of previous bariatric surgery
- •History of chronic inflammatory bowel disease
- •Presence of chronic diarrhea
- •Presence of a severe and evolutive life threatening pathology
- •Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer
- •Presence of an unhealed gastro-duodenal ulcer
- •Presence of Helicobacter pylori resistant to medical treatment
- •Presence of esophagitis
- •Pregnancy or desire to be pregnant during the study
- •Mentally unbalanced patients, under supervision or guardianship
- •Patients who don't understand French and not able to give consent
- •Patient included and followed in another interventional trial
- •Unable to consent, under tutelage or curatorship, or judiciary safeguard
结局指标
主要结局
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on weight loss (efficacy).
时间窗: 2 years after the surgery
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Efficacy: Weight loss according to Excess Weight Loss % (EWL%) calculated using the following formula: ((weight 2 years after surgery - initial weight) / (initial weight - ideal weight)) x 100. Ideal weight defined as the weight corresponding to a BMI = 25 kg/m². The assessment of the primary co-endpoint will be standardized between the sites.
To demonstrate that OAGB with 150 cm biliopancreatic limb is not inferior to RYGB on nutritional complication rate (safety)
时间窗: 2 years after the surgery
For each patient co-primary endpoints will be assessed at 2 years after surgery composed by: Safety: Nutritional complications defined by at least one vitamin deficiency (vit. B1 \< 66nmol/l or B12 \< 145pmol/l), malnutrition (albumin \< 30g/l), anemia (hemoglobin \< 10g/dl) or a combination of these. The assessment of the primary co-endpoint will be standardized between the sites.
次要结局
- Measurement of % of transferrin saturation(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of zinc(Before surgery and 6, 12 months and 24 months after surgery)
- Measurement of vitamin A(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of albumin(Before and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of pre-albumin(Before and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of prothrombin rate(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of HDL(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of hemoglobin(Before and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of calcium(Before and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of ferritin(Before and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of iron(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of vitamin B1(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of vitamin B9(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of vitamin B12(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of the 24-hour steatorrhea rate(6 month after surgery)
- Measurement of vitamin E(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of vitamin D(Before surgery and 6, 12 and 24 months after surgery)
- Measurement of HbA1c(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of fasting glycemia(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of LDL(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Evaluation of antihypertensive drugs(Before surgery and 6, 12 and 24 months after surgery)
- Hospitalization length(The last day of hospitalization)
- Occurrence of kidney stone(Within 2 years after surgery)
- Severity of early complications(Within 30 days after surgery)
- Measurement of cholesterol(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Measurement of triglycerides(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Evaluation of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea(Before surgery and 6, 12 and 24 months after surgery)
- Body composition(Before and 24 months after surgery.)
- Sarcopenia level(Before and 24 months after surgery.)
- Type of early complications(Within 30 days after surgery)
- Evaluation of antidiabetic drugs(Before surgery and 6, 12 and 24 months after surgery)
- Evaluation of antilipidemic drugs(Before surgery and 6, 12 and 24 months after surgery)
- Severity of late complications(Within 2 years after surgery)
- Gastroesophageal reflux assessment(Before surgery and 1, 3, 6, 12, 18 and 24 months after surgery)
- Number of patients readmitted(30 days after surgery)
- Overall complications rate(Within 24 months after surgery)
- Type of late complications(Within 2 years after surgery)
- Absolute weight loss assessment(1, 3, 6, 12, 18 and 24 months after surgery)
- Excess Weight Loss percentage assessment(1, 3, 6, 12, 18 and 24 months after surgery)
- Excess BMI Loss percentage assessment(1, 3, 6, 12, 18 and 24 months after surgery)
- Quality of life assessed with GIQLI questionnaire(Before surgery and at 6, 12 and 24 months after surgery)
- Quality of life assessed with SF36 questionnaire(Before surgery and at 6, 12 and 24 months after surgery)
- Quality of life assessed with Sigstad questionnaire(Before surgery and at 1, 3, 6, 12, 18 and 24 months after surgery)