Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis
研究概览
简要总结
GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
详细描述
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m2.
Presently, bariatric procedures are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric procedures. The natural history of GERD symptoms in this population after undergoing a bariatric treatment is scarce or conflicting. Moreover, silent or asymptomatic GERD prevalence has not been well established preoperatively. Evaluation and documentation of GERD may potentially change the planned bariatric procedure and avoid unnecessary additional surgeries or procedures to address symptomatic post-operative GERD.
The investigators hypothesized that GERD is more prevalent in patients undergoing surgical bariatric procedures, specifically laparoscopic vertical sleeve gastrectomy (VSG). This multi-center, prospective, cohort study can potentially clarify current debatable data, based mostly on retrospective studies, and can help clinicians to select the most appropriate bariatric treatment for the patients. Most importantly, by selecting the best approach based on preoperative GERD studies it could prevent long term complications of GERD and further unnecessary procedures for the bariatric patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 Kg/m2
- •Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
- •Patients older than 18 years and younger than 75 years of age at time of consent
- •Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
- •Patients willing and able to comply with study requirements for follow-up
排除标准
- •Any patient with BMI < 30 Kg/m2
- •Patients treated with intragastric balloons.
- •Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- •Esophageal, gastric or duodenal malignancy
- •Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- •Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- •Active fungal esophagitis
- •Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- •General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- •Pregnant or planning to become pregnant during period of study participation
- •Patient refuses or is unable to provide written informed consent
- •Prior bariatric treatment procedure
- •Prior surgical or endoscopic anti-reflux procedure
研究组 & 干预措施
Endoscopic sleeve gastroplasty
All obese patients who will be undergoing an endoscopic sleeve gastroplasty (ESG). As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the endoscopic sleeve gastroplasty patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed
干预措施: Endoscopy (Procedure)
Surgery (VSG or RYGBP)
All obese patients who will be undergoing either a vertical sleeve gastrectomy or a Roux-en-Y gastric bypass. As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the surgical procedure patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed
干预措施: Surgery (Procedure)
结局指标
主要结局
Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis
时间窗: 1 year
GERD symptoms, esophageal acid exposure time and/or esophagitis
次要结局
- Percentage of excess body weight (EBW) loss and total body weight loss (TBWL)(5 years)
- Percentage of participants on daily or twice daily PPI for GERD symptoms control, regardless of pH-monitoring results(5 years)
- Reflux esophagitis(5 years)
- GERD severity as assessed by GERD-Health related quality of life (HRQL) score(3,6,12,24,26,48, and 60 months post procedure)
- Prevalence and incidence of silent reflux(1 year)
- Percentage of patients with GERD at baseline in whom the planned bariatric intervention was changed due to abnormal ph testing or presence of erosive esophagitis, Barrett's esophagus, reflux related esophageal stricture(1 year)
- Difference in BMI after the bariatric procedure(5 years)
- GERD severity based on standardized Reflux Disease Questionnaire (RDQ)(3,6,12,24,26,48, and 60 months post procedure)
- Percent of patients with abnormal esophageal acid exposure time > 6% defined by Bravo pH monitoring (96 hours)(1 year)