Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Effectiveness of anti-reflux surgery
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of the US population. With the advent and increased use of esophageal impedance monitoring, both acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for optimal treatment. Though there are a handful of studies evaluating the efficacy of anti-reflux surgery on those patients with acid or non-acid related reflux disease, the comparison between acid and non-acid reflux disease following surgery is lacking. We propose a prospective study comparing clinical outcomes from those patients with acid versus non-acid reflux disease following anti-reflux surgery with the use of validated and disease specific quality of life surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are offered anti-reflux surgical treatment with elevated DeMeester scores or with low (less than 14.7) DeMeester scores, but with positive impedance scores (positive symptom index associated with reflux episodes).
排除标准
- •• Previous major upper gastrointestinal surgery (includes esophagus, stomach, and duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major upper GI surgery
- •Presence of paraesophageal hernia (type II - type IV)
- •Presence of large hiatal hernia >5cm
- •Presence of peptic strictures
- •History of severe esophageal motility disorders such as:
- •achalasia
- •diffuse esophageal spasms
- •scleroderma
- •poorly-controlled diabetes mellitus
- •autonomic or peripheral neuropathy
- •Pregnancy (As a standard operating procedure, women of child-bearing age will undergo a urine pregnancy test the morning of surgery because anti-reflux surgery is considered an elective case, where pregnancy is a relative contraindication.)
- •BMI greater than 40
- •Undergoes Collis gastroplasty during surgery
- •Conversion to an open procedure
- •Age less than 18 years old
结局指标
主要结局
Effectiveness of anti-reflux surgery
时间窗: 1 year
To prospectively evaluate the effectiveness of anti-reflux surgery, as measured by symptom reduction, in the treatment of nonacid reflux disease compared prospectively with acid reflux disease.
次要结局
未报告次要终点