Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

NCT03465280 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2022-01-11

No results posted yet for this study

Summary

Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment.

Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.

Conditions

Interventions

PROCEDURE

Microdebrider

Removal of lesions via microdebrider

PROCEDURE

Cold-steel surgery (forceps)

Removal of lesions via forceps

PROCEDURE

Carbon dioxide laser

Removal of lesions via carbon dioxide laser

PROCEDURE

Potassium titanyl phosphate (KTP) laser

Removal of lesions via KTP laser

PROCEDURE

Pulsed dye laser

Removal of lesions via pulsed dye laser

PROCEDURE

Radiofrequency ablation

Removal of lesions via radiofrequency ablation

PROCEDURE

Monopolar suction diathermy

Removal of lesions via monopolar suction diathermy

PROCEDURE

Plasma coagulation

Removal of lesions via plasma coagulation

PROCEDURE

Other

Removal of lesions via other methods

OTHER

Adjuvant therapies

All adjuvant therapies

Sponsors & Collaborators

  • Alder Hey Children's NHS Foundation Trust

    collaborator OTHER
  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • Newcastle-upon-Tyne Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Adam Donne · Alder Hey Children's NHS Foundation Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465280 on ClinicalTrials.gov