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poor recruitment
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The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.
This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adenoidectomy | Experimental |
| |
| Endoscopic Sinus surgery and Adenoidectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adenoidectomy versus endoscopic sinus surgery with adenoidectomy | Procedure | adenoidectomy versus endoscopic sinus surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| surgical outcome | 1 year |
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Inclusion Criteria:
Age 6-12 at time of study enrollment. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.
Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | United States |
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| ID | Term |
|---|---|
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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randomized controlled trial
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