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| ID | Type | Description | Link |
|---|---|---|---|
| 07-01-005 |
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| Name | Class |
|---|---|
| Rady Children's Hospital, San Diego | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | The conventional therapy arm will undergo debridement with either a powered microdebrider or cold instrumentation excision as per the preference of the individual surgeon. Debridement will be deemed complete after removal of gross papilloma to the extent that the individual surgeon feels can be safely accomplished. Standard microsurgical principles of the larynx will guide debridement in that no opposing mucosal surfaces of the true vocal folds, laryngeal ventricle or inter-arytenoid space will be simultaneously debrided | ||
| Experimental Arm | Patients enrolled into the conventional therapy plus PDL treatment arm will undergo debridement of the supraglottis and subglottis via conventional techniques as per the individual surgeons preferences followed by therapy to anterior commissure, true vocal folds, laryngeal ventricle and inter-arytenoid space with the pulsed dye laser. Standard laser settings will be a 450 microsecond pulse width, 5 J per pulse maximum of 1Hz, 1 mm spot fiber, 1-2 mm spot size and fluences of 38-255 J/cm2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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Children with severe JORRP
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hartnick, M.D. | Massachusetts Eye and Ear Infirmary | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | United States | |||
| Massachusetts Eye and Ear Infirmary |
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| ID | Term |
|---|---|
| C535297 | Recurrent respiratory papillomatosis |
| D010212 | Papilloma |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Boston |
| Massachusetts |
| 02114 |
| United States |