Postoperative Activity Restrictions in Children
Phase: NA
Conditions: Pediatric Post-operative Time to Return to Full Activity
Sponsor: Corewell Health East

Postoperative Activity Restrictions in Children After Routine Surgery 
1 
 
 
 
Title:  Postoperative Activity Restrictions in Children (PARC) 
 
NCT04145895 
 
Protocol approval date: 10/29/2021 
 
 
 
 

Postoperative Activity Restrictions in Children After Routine Surgery 
2 
 
 
Title:  Postoperative Activity Restrictions in Children (PARC) 
 
Principal Investigator: Pavan Brahmamdam, MD 
NCT04145895 
Protocol approval date: 10/29/2021 
IRB# 2019-224 
 
SUMMARY 
 
BACKGROUND: Currently, there are no evidence-based guidelines for postoperative activity 
restrictions in routine pediatric surgery. Recent studies suggest that patients may return to normal 
activity earlier than previously thought. We aim to compare time to full activity and post-operative 
outcomes. This study will describe family preferences for self-directed activity restrictions (SDAR) 
and physician directed activity restrictions (PDAR) following routine surgeries. 
 
STUDY DESIGN: Single institution, prospective clinical trial (NCT04145895). Patients who present 
for a routine inguinal hernia repair or laparoscopic appendectomy for uncomplicated appendicitis are 
eligible for participation. Participating families will choose to enroll in either the control (PDAR) or 
experimental (SDAR) groups. The PDAR patients are restricted from full activity for two weeks post-
operatively. For SDAR, patients are instructed to return to full activity when pain is improving and the 
family feels comfortable. At 4-6 weeks postoperatively, caregivers will complete a survey to assess 
time to resume full activity, time to return to school and work, surgical complications, and patient and 
caregiver satisfaction. 
 
 
 

Postoperative Activity Restrictions in Children After Routine Surgery 
3 
 
 
BACKGROUND AND SIGNIFICANCE 
 
Postoperative activity restrictions (PAR) serve to minimize the risk of complications and prevent 
stress on the operative site following abdominal surgery. By minimizing intra-abdominal pressure, 
PAR are used to prevent the breakdown of the surgical repair and closure.1 Commonly restricted 
activities include heavy lifting, exercise, and strenuous activity. As children are highly active by 
nature, limiting physical activity is difficult.2 Pediatric surgeons may restrict time to return to school or 
extracurricular activities. However, these restrictions create a societal burden through school 
absences and missed work days. Additionally, PAR can negatively impact a child’s psychosocial well- 
being and cause undue family stress.2 
 
PAR are physician-dependent as evidence-based guidelines for restrictions following routine pediatric 
surgery are not established. Recent studies demonstrate considerable variability in surgeons’ 
recommendations following laparoscopic appendectomy and inguinal hernia repair in children.1 The 
lack of consensus amongst physicians may be attributed to the corresponding lack of evidence in this 
area.3 A 2020 survey on surgeon recommendations for postoperative activity found that only 23.8% of 
respondents indicated that their recommendations were based on evidence in the literature.4 More 
than half of the respondents indicated that they followed practices learned in training, and 50.7% 
indicated that recommendations had been developed from previous experience.4 Others propose the 
use of self-directed activity restrictions (SDAR) following routine pediatric surgery.2 Proponents of 
SDAR suggest patients may safely return to normal activity earlier than previously thought. Additional 
benefits include greater patient and family satisfaction and quality of life. 
 
Prospective investigation is needed to develop evidence-based guidelines for PAR in the pediatric 
population. We conducted a single institution, prospective clinical trial (NCT04145895) to compare 
length of time to full activity, as well as, post-operative outcomes of SDAR and physician directed 
activity restrictions (PDAR) in children following inguinal hernia repair and laparoscopic 
appendectomy. Further, we aimed to describe the preference of families for SDAR or PDAR, patient 
and caregiver satisfaction, and parental time of work. This paper reports the preliminary results of this 
study. 
 
METHODS 
 
Participants 
This study was approved by the Beaumont Institutional Review Board (2019-224). Patients who 
presented to Beaumont Royal Oak and Beaumont Troy for a routine inguinal hernia repair (ages 2-13 
years) or laparoscopic appendectomy for uncomplicated appendicitis (ages 0-17 years) were eligible 
for participation. Patients meeting eligibility criteria (Figure 1) were identified by the pediatric 
surgeons, including the Primary Investigator (P.B.), and were provided with an information sheet 
detailing the study, which served as consent for participation. Parents and patients who elected to 
participate then chose to enroll in the control group (PDAR) or experimental group (SDAR). The 
PDAR instructions detailed that patients are restricted from full, normal activity for 2 weeks after their 
procedure. The SDAR instructions specified that they may return to full activity when their pain is 
improving and the parent, or guardian, feels comfortable advancing their activity. Enrollment is still 
accruing for this study. 
 
 
 
 
 
 

Postoperative Activity Restrictions in Children After Routine Surgery 
4 
 
0-18 years 
Uncomplicated 
appendicitis 
Uncomplicated 
2-13 years
Uncomplicated procedure
 
Figure 1. Patient eligibility criteria 
Figure 1. Patient eligibility criteria for participation in the clinical trial. 
 
Data Collection 
 
Baseline characteristics, comorbidities, surgical complications, length of stay, and pain medications 
will be obtained for each participant from the time of surgery. At 4-6 weeks postoperatively, parents 
or guardians will be asked to complete a survey at their follow-up appointment or online using 
Research Electronic Data Capture (REDCap). The survey includes assessments of the time taken 
to return to school and work, return to full activity, surgical complications, and patient and caregiver 
satisfaction (Figure 2). 
 
 
Figure 2. Postoperative Survey 
Your Child’s Experience Postoperatively 
For how long was your child on pain medications following the 
procedure? 
 1-2 days 
 3-4 days 
 4-7 days 
 >1 week 
How many days following the procedure did your child return to school, daycare, summer camp, or summer school? 
Approximately how many days after surgery did your child return to full activity (sports, gym, dance, outdoor play, etc.)? 
Did your child’s wound have any oozing or bleeding following 
discharge from the hospital? 
 None 
 Mild (slight drainage) 
 Moderate (drainage with blood) 
 Severe (oozing with blood) 
If you answered mild, moderate, or severe to the previous question, when did this occur? 
If you answered mild, moderate or severe to the previous question, did this require any treatment by your surgical team? 
Did your child experience any postoperative complications? 
 No 
 Yes 
If you answered yes to the previous question, please specify: 
After resuming full activity, did your child experience an increase 
in pain? 
 No 
 Yes 
If you answered yes to the previous question, did they require 
any medication for the pain? 
 No 
 Yes 
How compliant was your child with their postoperative 
instructions? 
 Compliant 
 Partially compliant 
 Not compliant 
Laparoscopic 
Appendectomy 
Inguinal Hernia Repair 

Postoperative Activity Restrictions in Children After Routine Surgery 
5 
 
How would you describe your child’s overall satisfaction 
following the procedure? 
 Very satisfied 
 Satisfied 
 Neither satisfied or dissatisfied 
 Dissatisfied 
 Very dissatisfied 
Your Experience Postoperatively 
What is your relationship to the child? 
 Mother 
 Father 
 Grandparent 
 Legal Guardian 
 Other 
Did you or another caregiver take time off work to care for your 
child following their procedure? 
 Yes 
 No 
Did you have to find additional childcare for your child following 
their procedure? 
 Yes 
 No 
How would you describe your overall satisfaction following your 
child’s procedure? 
 Very satisfied 
 Satisfied 
 Neither satisfied or dissatisfied 
 Dissatisfied 
 Very dissatisfied 
Were you satisfied with the instructions detailed in your 
discharge guidelines? 
 Very satisfied 
 Satisfied 
 Neither satisfied or dissatisfied 
 Dissatisfied 
 Very dissatisfied 
If your followed physician-directed instructions, did you follow the 
recommendations strictly? 
 Yes 
 No 
 Somewhat 
If you chose self-directed instructions, did you feel comfortable 
determining when your child was able to resume full activity? 
 
 I felt comfortable 
 I had some concerns 
 I did not feel comfortable 
  
Figure 2. Postoperative survey provided to patients 4-6 weeks following their procedure. Patients were able to complete the 
survey at their postoperative visit or online via REDCap. 
  

Postoperative Activity Restrictions in Children After Routine Surgery 
6 
 
 
 
 
Objectives 
 
The primary outcome of this study is length of time to full activity.  
Secondary outcomes will evaluate patient preference to PDAR and SDAR based on choice of study 
arm and the impact of restriction type on number of parental days off work.  
Clinical complications will also be tracked. Patient satisfaction will be defined as a cumulative score 
of three satisfaction factors (child, parent, and satisfaction with discharge guidelines). 
 
Statistical Analysis 
 
Continuous data will be presented as mean (SD) or median (IQR) depending on distribution, and 
analyzed using unpaired t tests or Mann Whitney ranked sum tests. Categorical data will be 
presented as number (%) and will be analyzed using Chi Square or Fisher’s exact test depending 
on frequencies P values <.05 will be considered significant. 
 
 
 
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