Pediatric Post-operative Time to Return to Full ActivityPARCNCT04145895
Postoperative Activity Restrictions in Children
A study testing Postoperative activity restrictions in people with Pediatric Post-operative Time to Return to Full Activity, run by Corewell Health East at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Post-operative Time to Return to Full Activity
- What is being tested?
- Postoperative activity restrictions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2020to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- 18 years or older
- Their child meets the inclusion criteria for participation in this study
Who cannot join
- 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
- Less than 18 years of age
- Their child does not meet the inclusion criteria for participation in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital
Troy, Michigan, 44201
About this study
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.
Read the 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.
- Being tested
- Postoperative activity restrictions
- Keywords
- Post-operative activity restriction, Pediatric inguinal hernia repair, Pediatric laparoscopic appendectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative activity restrictionsOther
Recommendations for return to full activity including return to school, sports, exercise, etc.
| Study group | Role | What they receive |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Other | Postoperative activity restrictions prescribed by physician. Receives: Other: Postoperative activity restrictions |
| Self-directed Postoperative Activity Restriction | Other | Postoperative activity restrictions self-determined (parent/guardian and/or patient). Receives: Other: Postoperative activity restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Outcomes - Clinical Complications
Number of child participants who developed post op complications
Measured: six weeks post op
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.
Measured: six weeks post op
Post Operative Outcomes - Length of Time to Return to Full Activity
Mean/Standard deviation (SD) number of days to return to full activity
Measured: six weeks post op
Secondary outcomes (3)
Number of Parents/Guardians Choosing Self-directed Post Operative Instructions
Number of parents/guardians who chose self-directed post operative instructions
Measured: six weeks post op
Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions
Number of parent/guardian who chose physician-directed post operative instructions
Measured: six weeks post op
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
Measured: six weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Feb 2020
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Post-operative Time to Return to Full ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, nonrandomized, parallel
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavan Brahmamdam, Corewell Health East
- Investigators
- Pavan Brahmamdam, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145895
- Sponsor's protocol ID
- 2019-224
- Acronym
- PARC
- Status last verified
- May 2023
- First submitted
- 25 Oct 2019
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30146309
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Activity Restrictions in Children
- ClinicalTrials.gov ID
- NCT04145895
- Acronym / sponsor ID
- PARC / 2019-224
- Keywords
- Post-operative activity restriction, Pediatric inguinal hernia repair, Pediatric laparoscopic appendectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 24 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, nonrandomized, parallel
| Arm | Type | Receives |
|---|---|---|
| Physician-directed Postoperative Activity Restriction | Other | Other: Postoperative activity restrictionsPostoperative activity restrictions prescribed by physician. |
| Self-directed Postoperative Activity Restriction | Other | Other: Postoperative activity restrictionsPostoperative activity restrictions self-determined (parent/guardian and/or patient). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 18 years or older
- Their child meets the inclusion criteria for participation in this study
Key exclusion criteria (6 listed)
- 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
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative activity restrictionsRecommendations for return to full activity including return to school, sports, exercise, etc. | Other | Physician-directed Postoperative Activity Restriction, Self-directed Postoperative Activity Restriction |
Primary outcome
Post Operative Outcomes - Clinical Complications
Time frame: six weeks post op
Number of child participants who developed post op complications
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.
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
3 secondary outcomes
Number of Parents/Guardians Choosing Self-directed Post Operative Instructions
Time frame: six weeks post op
Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions
Time frame: six weeks post op
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30146309Baumann 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavan Brahmamdam, MD principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative activity restrictions in people with Pediatric Post-operative Time to Return to Full Activity, run by Corewell Health East at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Outcomes - Clinical Complications (time frame: six weeks post op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.