N/A
N=20
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
Nasal Polyps · Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00215787 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Sep 2010
Primary outcome: Primary: Presence of Reflux in Patients With Polyposis — 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lansoprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Head and Neck Surgery Associates
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Reflux in Patients With Polyposis |
15 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00215787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.