ACTRN12623000462684尚未招募Unknown
Safety, Feasibility and Efficacy of Anti-Reflux Ablative Therapy (ARAT) in Patients with Gastroesophageal reflux disease (GERD) after Gastric Sleeve Surgery: A Prospective Cohort
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Indications confirmed via screening:
- •1.Persisting reflux symptoms if weaning from medication (PPI dependence)
- •2.Unacceptable life-long medication use
- •3.Intolerance to PPI due to medication related side effects
- •4.DeMeester score >14.72 or acid exposure to >6% (from 24 hour pH monitoring)
- •5.LA Grade A esophagitis or more (from previous gastroscopy)
- •Inclusion Criteria
- •1.Indication #1 and at least one other indication
- •2.Equal to or above 18 years of age or below 85 years of age
- •3.Patients who have undergone vertical sleeve gastrectomy
排除标准
- •1.Conditions of primary esophageal dysmotility (i.e Achalasia, Distal esophageal spasm, etc)
- •2.Conditions causing secondary esophageal disorders (i.e systemic sclerosis, dermatomyositis)
- •3.Peptic stricture
- •4.Malignancy of the esophagus
- •5.Barrett’s esophagus with dysplasia
- •6.Hill Grade 4
- •7.Eosinophilic Esophagitis at screening endoscopy
- •8.Previous gastro-esophageal surgery including surgical fundoplication procedures
- •9.Portal hypertension and esophageal varices
- •10.Significant comorbidities (Charleson index score >5 or ASA >2)
- •11.Coagulation disorders
- •12.Pregnancy
研究者
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