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Completed

NCT Number: NCT04145895

Postoperative Activity Restrictions in Children

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William Beaumont Hospital, Royal Oak, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative activity restrictions

Other

Recommendations for return to full activity including return to school, sports, exercise, etc.

Primary outcomes

  1. Post Operative Outcomes - Clinical Complications

    Time frame: six weeks post op

    Number of child participants who developed post op complications

  2. Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines)

    Time frame: 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.

  3. Post Operative Outcomes - Length of Time to Return to Full Activity

    Time frame: six weeks post op

    Mean/Standard deviation (SD) number of days to return to full activity

Secondary outcomes

  1. Number of Parents/Guardians Choosing Self-directed Post Operative Instructions

    Time frame: six weeks post op

    Number of parents/guardians who chose self-directed post operative instructions

  2. Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions

    Time frame: six weeks post op

    Number of parent/guardian who chose physician-directed post operative instructions

  3. Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group

    Time frame: six weeks post op

    Mean/SD number of days parents took off work during the post operative period

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Acronym: PARC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.