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

Primary Purpose

Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acclarent Relieva Balloon Sinuplasty

Adenoidectomy + Maxillary Sinus Irrigation

About this trial

This is an interventional treatment trial for Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis focused on measuring Pediatric Chronic Rhinosinusitis

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adenoidectomy without balloon dilation

Adenoidectomy with balloon dilation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01990820

First Posted

November 16, 2013

Last Updated

February 17, 2020

Sponsor

NorthShore University HealthSystem

1. Study Identification

Unique Protocol Identification Number

NCT01990820

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

September 29, 2016 (Actual)

Study Completion Date

September 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis

Keywords

Pediatric Chronic Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adenoidectomy without balloon dilation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Adenoidectomy with balloon dilation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Acclarent Relieva Balloon Sinuplasty

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

Intervention Description

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

Procedure

Intervention Name(s)

Adenoidectomy + Maxillary Sinus Irrigation

Intervention Description

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 Outcome Measure Information:

Title

Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.

Description

Time Frame

6 and 12 months postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Gerber, MD

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

Facility Information:

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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