Trial Outcomes & Findings for Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use (NCT NCT01561703)
NCT ID: NCT01561703
Last Updated: 2017-01-19
Results Overview
Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
6 wks post-operative appointment
Results posted on
2017-01-19
Participant Flow
Participant milestones
| Measure |
Intervention
Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
|
Control
Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use
Baseline characteristics by cohort
| Measure |
Intervention
n=20 Participants
Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
|
Control
n=24 Participants
Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
20 participants
n=5 Participants
|
24 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Gender
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 wks post-operative appointmentQuestionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.
Outcome measures
| Measure |
Intervention
n=20 Participants
Patients will receive postoperative antibiotic after surgery.
Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
|
Control
n=24 Participants
Patients will NOT receive postoperative antibiotic
No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics
|
|---|---|---|
|
Healthcare Utilization
Reported Fever
|
5 participants
|
16 participants
|
|
Healthcare Utilization
Made a phone call to clinic
|
5 participants
|
8 participants
|
|
Healthcare Utilization
ER/UR/Clinic visit
|
2 participants
|
9 participants
|
|
Healthcare Utilization
Received "additional" antibiotic
|
0 participants
|
6 participants
|
|
Healthcare Utilization
Diagnostic workup at ER
|
0 participants
|
6 participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Coordinator
University of Missouri - Department of Otolaryngology - Head and Neck Surgery
Phone: 5738822549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place