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Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02592902
Enrollment
60
Registered
2015-10-30
Start date
2014-04-30
Completion date
2018-09-30
Last updated
2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra Oesophageal Reflux, Laryngeal Cyst, Recurrent Respiratory Papillomatosis

Keywords

recurrent respiratory papillomatosis, extra oesophageal reflux, laryngeal cyst, phonosurgery, oesophageal impedance

Brief summary

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).

Detailed description

Recurrent respiratory papillomatosis (RRP) is a chronic viral disease, which affects children and adults as well. It is characterised by grow of squamous cell tumours on mucosa of aerodigestive tract, with predilection for the larynx. The disease is caused by the human papillomavirus (HPV). However, in contrast to the low incidence of RRP, HPV prevalence is common. It is indicated that other factors may contribute to the pathogenesis of RRP. One such factor might be extraesophageal reflux (EER). We investigated whether patients with RRP suffer more often from EER.

Interventions

PROCEDURESurgical collection of histology specimen

Collection of a histology specimen from the vocal cords and rear laryngeal commissure

PROCEDUREPerformance of immunohistochemical analysis

Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of EER (percentage)36 monthsThe occurrence of extra oesophageal reflux will be assessed in both study groups.

Secondary

MeasureTime frameDescription
Presence of pepsin36 monthsThe presence of pepsin (yes-no) will be assessed in both study groups.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026