Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
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.
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

 Risks include temporary dysphagia while the probe is in place, and nasal irritation. Mild,
 self-limited epistaxis has been rarely reported

 The procedure will be done within manufcturer guidelines under direct vision. Topical Afrin
 may be used to control any mild epistaxis. Topical 4% lidocaine will be applied to minimize
 dysphagia. These steps have proven very affective in minimizing these risks.

 If the study hypothesis is correct, the patient may have an diminished risk of recurrence of
 their nasal polyposis. If the patient is found to have previously undiagnosed reflux disease,
 this will allow it to be treated appropriately. Undiagnosed/untreated reflux has been
 associated with multiple medical problems including laryngeal and esophageal cancer. The
 patient will be given their PPI medication free of charge for the duration of the study. The
 noninvasive pH probe study will be done free of charge. No direct monetary payment will be
 given to participants.
Inclusion Criteria:

 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.

 Exclusion Criteria:

 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.