Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
Condition: Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
MeSH terms: Rhinitis; Sinusitis
Study type: Interventional

Summary: 
      Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease.
      Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of
      the throat) is performed since the adenoid pad may trap germs that enter a child's body and
      can get so swollen with bacteria that they become infected themselves. Functional endoscopic
      sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on
      children with this disease. Another treatment is adenoidectomy and irrigation of the
      maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate
      (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to
      answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon
      dilation of the maxillary sinus passage and irrigation experience improved quality of life
      outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with
      maxillary sinus irrigation without dilation of the sinus passage.
    


Intervention name(s): Acclarent Relieva Balloon Sinuplasty; Adenoidectomy + Maxillary Sinus Irrigation
Intervention type(s): Device; Procedure
Intervention description(s): A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.
Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.; A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.
Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.
After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home.
Other intervention name(s): Relieva Sinus Balloon Catheter 510K: K073041; Luma Illumination System 510K: K071845; Guide Cathetheter 510K: K043445; Votex Irrigation Catheter 510K: K043445; Guidewire 510K: K043445; Sidekick 510K: K043445; Inflation Devie 510K: K052198
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pediatric Chronic Rhinosinusitis