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Clinical Trials/NCT02592902
NCT02592902
Completed
Not Applicable

Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

University Hospital Ostrava1 site in 1 country60 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent Respiratory Papillomatosis
Sponsor
University Hospital Ostrava
Enrollment
60
Locations
1
Primary Endpoint
Occurrence of EER (percentage)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
September 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Ostrava
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurrence of EER (percentage)

Time Frame: 36 months

The occurrence of extra oesophageal reflux will be assessed in both study groups.

Secondary Outcomes

  • Presence of pepsin(36 months)

Study Sites (1)

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