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Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01990820
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : October 1, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
NorthShore University HealthSystem

Brief 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.

Condition or disease Intervention/treatment Phase
Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis Device: Acclarent Relieva Balloon Sinuplasty Procedure: Adenoidectomy + Maxillary Sinus Irrigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
Study Start Date : March 2009
Actual Primary Completion Date : September 29, 2016
Actual Study Completion Date : September 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Sinusitis

Arm Intervention/treatment
Active Comparator: Adenoidectomy without balloon dilation
Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
Procedure: Adenoidectomy + Maxillary Sinus Irrigation

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.


Experimental: Adenoidectomy with balloon dilation
Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
Device: Acclarent Relieva Balloon Sinuplasty

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.

Other Names:
  • 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




Primary Outcome Measures :
  1. Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia. [ Time Frame: 6 and 12 months postoperatively ]

    The care giver for each subject will be asked to complete SN-5 Pediatric sinonasal symptom survey (SN-5) at baseline (prior to surgery) and 6 and 12 months post surgery.

    The SN-5 is a health-related qualify of life (QOL) questionnaire which consists of 5 questions about sinus problems (sinus infection, nasal obstruction, allergy symptoms, emotional distress, activity limitations) each of which is scored by the caregiver on a 7 point response scale. The 5 responses are then averaged into an SN-5 overall score (1-7). 1 is the minimum value for the overall SN-5 (best QoL) and 7 is the maximum value (worst QoL) The questionnaire also asks the caregiver to grade overall health related quality of life using a visual analog scale from 0 (worse possible quality of life) to 10 (best possible quality of life). The visual analog scale is scored separately from the SN-5 average score.




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
  2. Failure to respond to 3-week course of antibiotic and 3 month course of nasal steroid preparations or antihistamines as well as saline nasal irrigation
  3. Rhinosinusitis documented by CT scan following oral antibiotic course.

Computer tomographic findings considered to be consistent with sinusitis include partial or complete sinus opacification.

Allergy and immunology workup will be recommended on an individual basis -

Exclusion Criteria:

  1. Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
  2. History of facial trauma that distorts sinus anatomy
  3. Ciliary dysfunction
  4. Pregnancy will be excluded.
  5. Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
  6. Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
  7. Patients with a history of sinus surgery or significant anatomic abnormalities on CT scan that would require endoscopic sinus surgery or septoplasty would also be excluded.

Of note, children who will be undergoing concurrent surgeries will not be excluded.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990820


Locations
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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
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Principal Investigator: Mark Gerber, MD NorthShore University HealthSystem

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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01990820    
Other Study ID Numbers: EH09-177
First Posted: November 21, 2013    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: February 19, 2020
Last Verified: February 2020
Keywords provided by NorthShore University HealthSystem:
Pediatric Chronic Rhinosinusitis
Additional relevant MeSH terms:
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Rhinitis
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases