Pediatric Post-operative Time to Return to Full Activity
Conditions
Keywords
Post-operative activity restriction, Pediatric inguinal hernia repair, Pediatric laparoscopic appendectomy
Brief summary
This study will investigate the need for and length of postoperative activity restrictions in children following a laparoscopic appendectomy or inguinal hernia repair. Currently, no consensus exists and restrictions are based on doctors' experience and preference. Children and their parents/guardians will decide if they wish to participate in this study. Those who wish to participate and who are eligible to participate will decide which postoperative activity restrictions they would like the child to follow. The child will follow either 1) doctor-directed restrictions or 2) self-directed restrictions.A parent or guardian will complete a survey 1-3 months after the procedure, to assess patient and family satisfaction and patient outcome.
Detailed description
Postoperative activity restrictions minimize the risk of surgical complications and prevent stress on the operative site. In the pediatric population, surgeons may restrict school attendance, participation in playground or gym, and participation in contact sports or heavy lifting. Currently, surgeons give pediatric patients postoperative restrictions following routine pediatric procedures (laparoscopic appendectomy and inguinal hernia repair) without evidence-based clinical practice guidelines. However, there is considerable variability amongst surgeons. It is common practice to provide some level of postoperative restrictions, which are primarily based on the surgeon's experience.While many surgeons prescribe specific postoperative instructions, some recommend self-directed restrictions. Self-directed restrictions instruct that the child return to school and normal physical activity when they and parents feel they are able to do so. There is no evidence that this practice is associated with any adverse outcomes. This study will utilize a convenience sample of pediatric patients treated at Beaumont Royal Oak and Troy for routine inguinal hernia repair and laparoscopic appendectomy. There will be two populations: patients undergoing the procedures (Patient population) and their parents/guardians (Parent population) who will be completing the postoperative survey. Both parents/guardians and children were enrolled. The Principal Investigator will review the operating room schedule and identify patients who are scheduled for either of the two procedures. Parents and patients who are eligible to participate in the study will be approached, the study explained and voluntary consent obtained. The participants will be provided an information sheet detailing the study, the risks, and the benefits. The researchers will describe the two groups the participant can enroll in. If the parents decide to enroll their child in the study they will then choose to be in either the control group (physician-directed) or the variable group (self-directed). The control group will be those individuals who choose physician-directed instructions which detail that they can resume all normal activity 2 weeks after their procedure. The experimental group will be those individuals who choose self-directed instructions which specify that they may return to full activity when their pain is improving and the parent feels comfortable with them doing so. For each group, the family will be provided with discharge instructions, a copy of these discharge instructions are provided in the study documents. A parent or guardian will complete a postoperative survey 1-3 months post procedure. The survey will assess: time of pain medication, time to return to school, time to resume full activity, wound healing, postoperative complications, changes in pain, compliance with instructions, patient satisfaction, time parent took off from work, if additional childcare was needed following the procedure, and parental satisfaction with the procedure and postoperative instructions.
Interventions
OTHERPostoperative activity restrictions
Recommendations for return to full activity including return to school, sports, exercise, etc.
Sponsors
Corewell Health East
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, nonrandomized, parallel
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for Patients: * Patient being treated at Royal Oak or Troy Beaumont for a routine inguinal hernia repair or appendectomy * For inguinal hernia repair: 2-13 years of age * For appendectomy: less than 18 years
Exclusion criteria
for Patients: * Older than 18 years of age upon admission * Patients with perforated or complicated appendicitis * For laparoscopic appendectomy: patient required a conversion to open appendectomy * Patient experienced a complicated procedure or concomitant operation Inclusion Criteria for Parent/Guardians: * 18 years or older * Their child meets the inclusion criteria for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines) | six weeks post op | 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. |
| Post Operative Outcomes - Clinical Complications | six weeks post op | Number of child participants who developed post op complications |
| Post Operative Outcomes - Length of Time to Return to Full Activity | six weeks post op | Mean/Standard deviation (SD) number of days to return to full activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group | six weeks post op | Mean/SD number of days parents took off work during the post operative period |
| Number of Parents/Guardians Choosing Self-directed Post Operative Instructions | six weeks post op | Number of parents/guardians who chose self-directed post operative instructions |
| Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions | six weeks post op | Number of parent/guardian who chose physician-directed post operative instructions |
Countries
United States
Participant flow
Pre-assignment details
Total enrollment numbers represent both children and parents/guardians.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 62 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Self-directed Postoperative Activity Restriction | Total | Physician-directed Postoperative Activity Restriction |
|---|---|---|---|
| Age, Continuous | 11.3 years STANDARD_DEVIATION 3.2 | 10.5 years STANDARD_DEVIATION 3.8 | 8.0 years STANDARD_DEVIATION 4.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 62 participants | 82 participants | 20 participants |
| Sex: Female, Male Female | 25 Participants | 33 Participants | 8 Participants |
| Sex: Female, Male Male | 37 Participants | 49 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 62 |
| other Total, other adverse events | 2 / 20 | 5 / 62 |
| serious Total, serious adverse events | 0 / 20 | 0 / 62 |
Outcome results
Primary
Post Operative Outcomes - Clinical Complications
Number of child participants who developed post op complications
Time frame: six weeks post op
Population: data analyzed only for child participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Post Operative Outcomes - Clinical Complications | 2 Participants |
| Self-directed Postoperative Activity Restriction | Post Operative Outcomes - Clinical Complications | 5 Participants |
Primary
Post Operative Outcomes - Length of Time to Return to Full Activity
Mean/Standard deviation (SD) number of days to return to full activity
Time frame: six weeks post op
Population: Data analyzed for child participants with survey responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician-directed Postoperative Activity Restriction | Post Operative Outcomes - Length of Time to Return to Full Activity | 11.9 days | Standard Deviation 7.5 |
| Self-directed Postoperative Activity Restriction | Post Operative Outcomes - Length of Time to Return to Full Activity | 8.9 days | Standard Deviation 5.3 |
Primary
Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines)
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.
Time frame: six weeks post op
Population: Both children and parents completed satisfaction surveys. Satisfaction data available only for the n=106 who completed the post-op survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines) | 0 score on a scale |
| Self-directed Postoperative Activity Restriction | Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines) | 0 score on a scale |
Secondary
Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group
Mean/SD number of days parents took off work during the post operative period
Time frame: six weeks post op
Population: data analyzed for parents who reported taking time off in survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physician-directed Postoperative Activity Restriction | 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 |
| Self-directed Postoperative Activity Restriction | Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group | 1.4 days | Standard Deviation 2.7 |
Secondary
Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions
Number of parent/guardian who chose physician-directed post operative instructions
Time frame: six weeks post op
Population: data analyzed only for parent/guardian participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions | 20 Participants |
| Self-directed Postoperative Activity Restriction | Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions | 0 Participants |
Secondary
Number of Parents/Guardians Choosing Self-directed Post Operative Instructions
Number of parents/guardians who chose self-directed post operative instructions
Time frame: six weeks post op
Population: data analyzed only for parent/guardian participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Number of Parents/Guardians Choosing Self-directed Post Operative Instructions | 0 Participants |
| Self-directed Postoperative Activity Restriction | Number of Parents/Guardians Choosing Self-directed Post Operative Instructions | 62 Participants |