Trial Outcomes & Findings for Postoperative Activity Restrictions in Children (NCT NCT04145895)
NCT ID: NCT04145895
Last Updated: 2024-01-24
Results Overview
Number of child participants who developed post op complications
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
168 participants
Primary outcome timeframe
six weeks post op
Results posted on
2024-01-24
Participant Flow
Total enrollment numbers represent both children and parents/guardians.
Participant milestones
| Measure |
Physician-directed Postoperative Activity Restriction
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
126
|
|
Overall Study
COMPLETED
|
40
|
124
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Physician-directed Postoperative Activity Restriction
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physician-directed Postoperative Activity Restriction
n=20 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=62 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.0 years
STANDARD_DEVIATION 4.4 • n=20 Participants
|
11.3 years
STANDARD_DEVIATION 3.2 • n=62 Participants
|
10.5 years
STANDARD_DEVIATION 3.8 • n=82 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
25 Participants
n=62 Participants
|
33 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
37 Participants
n=62 Participants
|
49 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
62 participants
n=62 Participants
|
82 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: six weeks post opPopulation: data analyzed only for child participants
Number of child participants who developed post op complications
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=20 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=62 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Post Operative Outcomes - Clinical Complications
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: six weeks post opPopulation: Both children and parents completed satisfaction surveys. Satisfaction data available only for the n=106 who completed the post-op survey.
Median satisfaction score ranging from 0-12 on a scale where 0=very satisfied, 1= satisfied, 2= neither satisfied nor dissatisfied, 3= dissatisfied, 4= very dissatisfied, and defined as combination of child + parent + discharge guidelines satisfaction ratings. Lower numbers = more satisfaction.
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=22 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=84 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines)
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: six weeks post opPopulation: Data analyzed for child participants with survey responses.
Mean/Standard deviation (SD) number of days to return to full activity
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=11 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=41 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Post Operative Outcomes - Length of Time to Return to Full Activity
|
11.9 days
Standard Deviation 7.5
|
8.9 days
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: six weeks post opPopulation: data analyzed only for parent/guardian participants
Number of parents/guardians who chose self-directed post operative instructions
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=20 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=62 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Number of Parents/Guardians Choosing Self-directed Post Operative Instructions
|
0 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: six weeks post opPopulation: data analyzed only for parent/guardian participants
Number of parent/guardian who chose physician-directed post operative instructions
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=20 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=62 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions
|
20 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: six weeks post opPopulation: data analyzed for parents who reported taking time off in survey
Mean/SD number of days parents took off work during the post operative period
Outcome measures
| Measure |
Physician-directed Postoperative Activity Restriction
n=10 Participants
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=36 Participants
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group
|
2.1 days
Standard Deviation 4.3
|
1.4 days
Standard Deviation 2.7
|
Adverse Events
Physician-directed Postoperative Activity Restriction
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Self-directed Postoperative Activity Restriction
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Physician-directed Postoperative Activity Restriction
n=20 participants at risk
Postoperative activity restrictions prescribed by physician.
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
Self-directed Postoperative Activity Restriction
n=62 participants at risk
Postoperative activity restrictions self-determined (parent/guardian and/or patient).
Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc.
|
|---|---|---|
|
Infections and infestations
infection requiring antibiotics
|
5.0%
1/20 • Number of events 1 • 6 months post procedure
adverse event data not collected from parents
|
3.2%
2/62 • Number of events 2 • 6 months post procedure
adverse event data not collected from parents
|
|
Surgical and medical procedures
anesthesia reaction
|
5.0%
1/20 • Number of events 1 • 6 months post procedure
adverse event data not collected from parents
|
0.00%
0/62 • 6 months post procedure
adverse event data not collected from parents
|
|
Skin and subcutaneous tissue disorders
skin inflammation
|
0.00%
0/20 • 6 months post procedure
adverse event data not collected from parents
|
1.6%
1/62 • Number of events 1 • 6 months post procedure
adverse event data not collected from parents
|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/20 • 6 months post procedure
adverse event data not collected from parents
|
1.6%
1/62 • Number of events 1 • 6 months post procedure
adverse event data not collected from parents
|
|
Skin and subcutaneous tissue disorders
drug rash
|
0.00%
0/20 • 6 months post procedure
adverse event data not collected from parents
|
1.6%
1/62 • Number of events 1 • 6 months post procedure
adverse event data not collected from parents
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place