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临床试验/NCT00260572
NCT00260572进行中(未招募)不适用

Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 1999年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,500
试验地点
2

研究概览

简要总结

The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.

详细描述

GERD is a significant public health problem and when it is severe it may have a considerable impact on patients' QOL. Relatively new treatments such as proton pump inhibitors (PPI) and laparoscopic fundoplication (wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux) are now available. Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments. Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD.

This study's goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD. In addition we want to measure standard outcomes such as morbidity, mortality, medication use and patient derived outcomes such as general and disease specific QOL, and patient satisfaction with the treatment. We also want to assess if and how long QOL is improved by medical and surgical treatment methods. In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical (an operation) rather than the medical treatment. It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD. Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment.

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

入选标准

  • Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:
  • heartburn
  • acid regurgitation
  • waterbrash
  • non-cardiac chest pain
  • dyspepsia
  • Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
  • Patients scheduled for surgical management of GERD and/or hiatal hernia
  • Patients currently or commencing treatment with at least proton pump inhibitors or pro-motility agents.

排除标准

  • Patients unable to comprehend or complete the QOL instruments.
  • Patients less than 18 years of age.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Luketich

MD

University of Pittsburgh

研究点 (2)

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