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

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.

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Key information

Conditions

Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Sinusitis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
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
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

Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
History of facial trauma that distorts sinus anatomy
Ciliary dysfunction
Pregnancy will be excluded.
Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
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.

Treatment and study plan

Acclarent Relieva Balloon Sinuplasty

Device

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

Adenoidectomy + Maxillary Sinus Irrigation

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Official study title

A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Nov 21, 2013
Registry last updated: Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed