Effectiveness of Anti-reflux Surgery for the Cure of Chronic Cough Associated With Gastro-oesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Global Results and Resolution of chronic cough
研究概览
简要总结
The effectiveness of surgical fundoplication in treating classical reflux symptoms is well documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.
The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15% to 95%; the spread of these data is largely attributable to disparate study design and methodology, patient selection, and outcome metrics.
In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough allegedly secondary to GERD and to eventually identify the preoperative clinical profile which could predict those positive effects, we considered two groups of patients presenting with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.
详细描述
Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy and esophageal manometry.
The type and severity of symptoms and the grade of reflux oesophagitis were scored using a questionnaire with semi-quantitative scales.
The upper gastro-intestinal (GI) endoscopy, barium swallow and esophageal manometry were performed according to standard techniques; reflux esophagitis was reported according to the Los Angeles classification. In the absence of Los Angeles grade A or higher esophagitis, patient underwent a 24h pH-recording or intraluminal impedance/pH monitoring. Patients complaining of chronic cough were submitted to a specific work-up consisting of a chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry in order to exclude pulmonary diseases.
Surgery was performed in patients negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, in consideration of the fact that patients had been referred mainly for the therapy of chronic cough.
The study was started in 1995 and it was closed in 2010.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged > 18 years, affected by chronic cough (> 8 weeks)associated with GERD typical symptoms, negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, undergoing anti-reflux surgery
排除标准
- •patients with chronic cough (> 8 weeks) positive for pulmonary diseases on chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry; association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders, redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach,on the diaphragm.
结局指标
主要结局
Global Results and Resolution of chronic cough
时间窗: minimum 12 months
Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy, esophageal manometry, chest High Resolution Computed Tomography scan, methacholine challenge test and spirometry. Surgery was performed on patients positive for gastro-esophageal reflux disease and negative for pulmonary diseases. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (form 0 = absence of symptoms or esophagitis, to 3 = severe symptoms and esophagitis.For the surgical results an evaluation scale , from "excellent" to "poor", was used.
次要结局
未报告次要终点
研究者
Sandro Mattioli
Associate Professor
University of Bologna