Recurrent Respiratory Papillomatosis
Conditions
Keywords
Papilloma, Papillomatosis, Laser, Laser Surgery
Brief summary
The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.
Interventions
None listed
Sponsors
Rady Children's Hospital, San Diego
Massachusetts Eye and Ear Infirmary
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention 2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP
Exclusion criteria
1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment. 2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7. 3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language. 4. Children whose families do not sign an informed consent to enter into the study. 5. Children whose families anticipate discontinuing care at a participating institution during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis | One Year |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score | One Year |
Countries
United States
Outcome results
None listed