Postoperative Activity Restrictions in Children

Pediatric Post-operative Time to Return to Full Activity Clinical Trial

— PARC  

Official title:

Postoperative Activity Restrictions in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145895
• Other study ID #: 2019-224
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 14, 2022

Study information

• Verified date: May 2023
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria for Parent/Guardians:

• Less than 18 years of age

• Their child does not meet the inclusion criteria for participation in this study

Related Conditions & MeSH terms

• Pediatric Post-operative Time to Return to Full Activity

Intervention

Other:
• Postoperative activity restrictions
Recommendations for return to full activity including return to school, sports, exercise, etc.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospital	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baumann LM, Williams K, Ghomrawi H, Abdullah F. Current practice patterns for postoperative activity restrictions in children. J Pediatr Surg. 2019 Jul;54(7):1432-1435. doi: 10.1016/j.jpedsurg.2018.06.025. Epub 2018 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Outcomes - Clinical Complications	Number of child participants who developed post op complications	six weeks post op
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.	six weeks post op
Primary	Post Operative Outcomes - Length of Time to Return to Full Activity	Mean/Standard deviation (SD) number of days to return to full activity	six weeks post op
Secondary	Number of Parents/Guardians Choosing Self-directed Post Operative Instructions	Number of parents/guardians who chose self-directed post operative instructions	six weeks post op
Secondary	Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions	Number of parent/guardian who chose physician-directed post operative instructions	six weeks post op
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	six weeks post op