Clinical trial NCT04145895: Postoperative Activity Restrictions in Children
Official title: Postoperative Activity Restrictions in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Post-operative Time to Return to Full Activity
Keywords: Post-operative activity restriction
Pediatric inguinal hernia repair
Pediatric laparoscopic appendectomy
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, nonrandomized, parallel
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post Operative Outcomes - Clinical Complications
timeFrame: six weeks post op
measure: Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines)
timeFrame: six weeks post op
measure: Post Operative Outcomes - Length of Time to Return to Full Activity
timeFrame: six weeks post op
Secondary outcomes:
measure: Number of Parents/Guardians Choosing Self-directed Post Operative Instructions
timeFrame: six weeks post op
measure: Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions
timeFrame: six weeks post op
measure: Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group
timeFrame: six weeks post op
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Pavan Brahmamdam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.