N/A
N=168
Postoperative Activity Restrictions in Children
Pediatric Post-operative Time to Return to Full Activity
Bottom Line
View on ClinicalTrials.gov: NCT04145895 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Post Operative Outcomes - Clinical Complications — 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Postoperative activity restrictions (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Outcomes - Clinical Complications |
2; 5 | — |
| PRIMARY Post Operative Outcomes - Patient Satisfaction (Combination of Child, Parent and Satisfaction With Discharge Guidelines) |
0; 0 | — |
| PRIMARY Post Operative Outcomes - Length of Time to Return to Full Activity |
11.9; 8.9 | — |
| SECONDARY Number of Parents/Guardians Choosing Self-directed Post Operative Instructions |
0; 62 | — |
| SECONDARY Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions |
20; 0 | — |
| SECONDARY Number of Parental Days Off Work Taken in the Self-directed Post Operative Course Group Versus Physician-directed Course Group |
2.1; 1.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04145895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.