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

NCT ID: NCT01990820

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-09-29

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.

Conditions

Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adenoidectomy without balloon dilation

Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.

Group Type: ACTIVE_COMPARATOR

Adenoidectomy + Maxillary Sinus Irrigation

Intervention Type: 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.

Adenoidectomy with balloon dilation

Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation

Group Type: EXPERIMENTAL

Acclarent Relieva Balloon Sinuplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention 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

Eligibility 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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• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

NorthShore University HealthSystem

Evanston, Illinois, United States

Countries

United States

Other Identifiers

EH09-177

Identifier Type: -

Identifier Source: org_study_id