Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215787
Status:
COMPLETED
Last Update Posted:
2010-09-22
First Post:
2005-09-15
Brief Title:
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
Sponsor:
Head and Neck Surgery Associates
Organization:
Head and Neck Surgery Associates
Study Overview
Official Title:
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 PIs 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 Undiagnoseduntreated 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
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 PIs 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 Undiagnoseduntreated 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None