Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
|
Outcome Measures
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. [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.
Eligibility Criteria
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.
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
Sponsors and Collaborators
- NorthShore University HealthSystem
Investigators
- Principal Investigator: Mark Gerber, MD, NorthShore University HealthSystem
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EH09-177
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 4 participants were enrolled on incorrect consent forms so their data were not collected. The IRB provided approval to enroll additional patients to make up for these 4 patients. |
| Arm/Group Title | Arm 1 | Arm 2 |
|---|---|---|
| Arm/Group Description | Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. 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. | Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation 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. |
| Period Title: Overall Study | ||
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Arm/Group Description | Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. 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. | Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation 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. | Total of all reporting groups |
| Overall Participants | 13 | 12 | 25 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
7.0
(2.9)
|
6.5
(2.1)
|
6.75
(2.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
53.8%
|
6
50%
|
13
52%
|
| Male |
6
46.2%
|
6
50%
|
12
48%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
Outcome Measures
| Title | Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia. |
|---|---|
| Description | 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. |
| Time Frame | 6 and 12 months postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adenoidectomy Without Balloon Dilation | Adenoidectomy With Balloon Dilation |
|---|---|---|
| Arm/Group Description | Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. | Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation |
| Measure Participants | 13 | 12 |
| SN-5 overall score (6 months postoperatively) |
2.48
(0.62)
|
2.5
(1.42)
|
| SN-5 overall score (12 months postoperatively |
2.25
(0.86)
|
2.40
(1.11)
|
| Quality of Life score (6 month) |
8.10
(0.88)
|
8.27
(2.10)
|
| Quality of Life score (12 months) |
8.27
(1.27)
|
7.60
(1.71)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1 | Arm 2 | ||
| Arm/Group Description | Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation. | Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation | ||
All Cause Mortality |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/12 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/13 (0%) | 0/12 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Mark Gerber |
|---|---|
| Organization | NorthShore University HealthSystem |
| Phone | 847-504-3300 |
| mgerber@northshore.org |
- EH09-177