Recurrent Respiratory Papillomatosis Clinical Trial
Official title:
Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Verified date | February 2019 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study was to determine, whether patients with recurrent respiratory papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with laryngeal cyst (control group).
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 75 Years |
Eligibility |
Inclusion Criteria: - age 1-75 years - cooperating patients with laryngeal papillomatosis - patients tolerating impedance probe - signed informed consent, consent with the examinations - control group of patients with a cyst or vocal cord polyp (reflux finding score 0-2) and/or patients indicated to augmentation, medialization or lateralization of the vocal cords Exclusion Criteria: - patients non-tolerating impedance catheter - patients who do not understand Czech language - patients who do not proclaim consent with enrolment into the study - patients who do not proclaim consent with the planned examinations - patients after surgical treatment of tumour of the swallowing or respiratory tract |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava-Poruba | Czech Republic |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135. Review. — View Citation
Gallagher TQ, Derkay CS. Pharmacotherapy of recurrent respiratory papillomatosis: an expert opinion. Expert Opin Pharmacother. 2009 Mar;10(4):645-55. doi: 10.1517/14656560902793530 . Review. — View Citation
Gallagher TQ, Derkay CS. Recurrent respiratory papillomatosis: update 2008. Curr Opin Otolaryngol Head Neck Surg. 2008 Dec;16(6):536-42. doi: 10.1097/MOO.0b013e328316930e. — View Citation
Goon P, Sonnex C, Jani P, Stanley M, Sudhoff H. Recurrent respiratory papillomatosis: an overview of current thinking and treatment. Eur Arch Otorhinolaryngol. 2008 Feb;265(2):147-51. Epub 2007 Nov 29. Review. — View Citation
Kashima HK, Shah F, Lyles A, Glackin R, Muhammad N, Turner L, Van Zandt S, Whitt S, Shah K. A comparison of risk factors in juvenile-onset and adult-onset recurrent respiratory papillomatosis. Laryngoscope. 1992 Jan;102(1):9-13. — View Citation
Maloney EM, Unger ER, Tucker RA, Swan D, Karem K, Todd NW, Reeves WC. Longitudinal measures of human papillomavirus 6 and 11 viral loads and antibody response in children with recurrent respiratory papillomatosis. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):711-5. — View Citation
Mammas IN, Sourvinos G, Spandidos DA. Human papilloma virus (HPV) infection in children and adolescents. Eur J Pediatr. 2009 Mar;168(3):267-73. doi: 10.1007/s00431-008-0882-z. Epub 2008 Dec 3. Review. — View Citation
McKenna M, Brodsky L. Extraesophageal acid reflux and recurrent respiratory papilloma in children. Int J Pediatr Otorhinolaryngol. 2005 May;69(5):597-605. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of EER (percentage) | The occurrence of extra oesophageal reflux will be assessed in both study groups. | 36 months | |
Secondary | Presence of pepsin | The presence of pepsin (yes-no) will be assessed in both study groups. | 36 months |
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