Trial Outcomes & Findings for Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty (NCT NCT01990820)
NCT ID: NCT01990820
Last Updated: 2020-02-19
Results Overview
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.
COMPLETED
NA
25 participants
6 and 12 months postoperatively
2020-02-19
Participant Flow
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.
Participant milestones
| Measure |
Arm 1
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.
|
Arm 2
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=13 Participants
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.
|
Arm 2
n=12 Participants
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
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.0 years
STANDARD_DEVIATION 2.9 • n=13 Participants
|
6.5 years
STANDARD_DEVIATION 2.1 • n=12 Participants
|
6.75 years
STANDARD_DEVIATION 2.5 • n=25 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
6 Participants
n=12 Participants
|
13 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
6 Participants
n=12 Participants
|
12 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 and 12 months postoperativelyThe 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.
Outcome measures
| Measure |
Adenoidectomy Without Balloon Dilation
n=13 Participants
Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.
|
Adenoidectomy With Balloon Dilation
n=12 Participants
Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation
|
|---|---|---|
|
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.
SN-5 overall score (12 months postoperatively
|
2.25 score on a scale
Standard Deviation 0.86
|
2.40 score on a scale
Standard Deviation 1.11
|
|
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.
Quality of Life score (6 month)
|
8.10 score on a scale
Standard Deviation 0.88
|
8.27 score on a scale
Standard Deviation 2.10
|
|
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.
SN-5 overall score (6 months postoperatively)
|
2.48 score on a scale
Standard Deviation 0.62
|
2.5 score on a scale
Standard Deviation 1.42
|
|
Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.
Quality of Life score (12 months)
|
8.27 score on a scale
Standard Deviation 1.27
|
7.60 score on a scale
Standard Deviation 1.71
|
Adverse Events
Arm 1
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place