Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Marginal ulcer rates
研究概览
简要总结
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •BMI> 35 kg/m2
- •2 years of controlled conservative obesity treatment without weight reduction
- •patients should give their consent to participate in the study
排除标准
- •Less than 2 years of conservative obesity treatment
- •cirrhosis Child-Pough score A
- •Crohn's disease
- •serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
- •drug consumption
- •non-compliance
- •hiatal hernia > 4cm
- •gastric pouch < 10cm
- •Barett esophagus
- •erosive esophagitis Grade C or D according to the Los Angeles Classification
- •endoscopically proven gastric stricture
- •acid exposition time > 6% (Lyon criteria)
- •reflux episodes> 80 /24 hours (Lyon criteria)
- •insufficient low esophageal sphincter according to manometry findings
- •pathological findings in the impedance pH-metry (acid and non-acid reflux)
结局指标
主要结局
Marginal ulcer rates
时间窗: 5 years post surgery
Assessment of age as risk factor for marginal ulcer development
时间窗: 5 years post surgery
Age of participants will be measured in years
Assessment of gender as risk factor for marginal ulcer development
时间窗: 5 years post surgery
The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
Assessment of tobacco use as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
Assessment of alcohol use as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
Assessment of diabetes mellitus as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Assessment of dyslipidemia as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
时间窗: 5 years post surgery
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
次要结局
- Total weight loss % (TWL)(5 years post surgery)
- Late morbidity (>30 days)(5 years)
- Changes of esophageal motor function(5 years post surgery)
- Excess BMI loss (EBL)(5 years post surgery)
- Incidence of Barrett's esophagus(5 years post surgery)
- Esophageal acid or bolus exposure(5 years post surgery)
- Number of acid or alcaline reflux events(5 years post surgery)
- Excess weight loss % (EWL)(5 years post surgery)
- Reflux-associated symptoms(5 years post surgery)
- Reflux-associated quality of life (QoL): GERD-HRQL(5 years post surgery)
- Total BMI loss (TBL)(5 years post surgery)
- Incidence of gastroesopagheal reflux disease (GERD)(5 years post surgery)
- Obesity- related quality of life (QoL): BAROS(2 years post surgery)
- Gastrointestinal quality of life (QoL): GIQLI(5 years post surgery)
- Obesity- related quality of life: BAROS(5 years post surgery)
研究者
Marko Kraljevic, MD
Principal Investigator
Spital Limmattal Schlieren