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临床试验/NCT00215787
NCT00215787已完成不适用

Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Head and Neck Surgery Associates2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年9月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Presence of Reflux in Patients With Polyposis

研究概览

简要总结

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%.

The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

详细描述

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%.

The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

Eligible patients found to have nasal polyps will be offered the chance to participate in this study. They will undergo non-invasive pH probe monitoring for 24 hours. If extraesophageal (laryngopharyngeal) reflux is discovered, they will be provided (at no cost) proton pump inhibitor medication (PPI), prescribed in accordance with published standards in the otolaryngology literature. Their polyposis will be treated as any other patient presenting with polyposis; participation in the study will not affect the course of polyp treatment. The incidence of recurrence will be monitored and recorded over the first year after treatment.

Included: Subjects will be adults with nasal polyposis, recruited from the PI's private practice, will not be currently taking a PP!, will be able and willing to undergo a noninvasive 24 hour pH probe study, and willing to take a PPI. Excluded: patients who are pregnant, have a history of surgical treatment for reflux disease, history of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period, and those not meeting inclusion criteria.

In addition to routine office otolaryngology examination, subjects will undergo noninvasive 24 hour esophageal pH probe monitoring. The probe is swallowed and placed in the same manner as a feeding tube. The procedure is done in the office. No sedation is required, but the mucosa may be sprayed with topical 4% lidocaine for comfort. This procedure is the standard for diagnosis of extraesophageal (laryngopharyngeal) reflux, and will be performed in accordance with manufacturer guidelines

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Subjects will:
  • Be adults with nasal polyposis
  • recruited from the PI's private practice
  • Not be currently taking a PPI
  • Be able and willing to undergo a noninvasive 24 hour pH probe study; and
  • Take a PPI.

排除标准

  • Patients who:
  • Are pregnant
  • Have a history of surgical treatment for reflux disease
  • History of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period; and
  • Do not meet inclusion criteria.

结局指标

主要结局

Presence of Reflux in Patients With Polyposis

时间窗: one year

Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.

次要结局

未报告次要终点

研究者

发起方
Head and Neck Surgery Associates
申办方类型
Other

研究点 (2)

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