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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician-directed Postoperative Activity Restriction | Other | Postoperative activity restrictions prescribed by physician. |
|
| Self-directed Postoperative Activity Restriction | Other | Postoperative activity restrictions self-determined (parent/guardian and/or patient). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative activity restrictions | Other | Recommendations for return to full activity including return to school, sports, exercise, etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Outcomes - Clinical Complications | Number of child participants who developed post op complications | 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. | 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 | six weeks post op |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Parent/Guardians Choosing Physician-directed Post Operative Instructions |
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Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Inclusion Criteria for Parent/Guardians:
Exclusion Criteria for Parent/Guardians:
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| Name | Affiliation | Role |
|---|---|---|
| Pavan Brahmamdam, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| William Beaumont Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30146309 | Result | 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. |
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Total enrollment numbers represent both children and parents/guardians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physician-directed Postoperative Activity Restriction | Postoperative activity restrictions prescribed by physician. Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. |
| FG001 | Self-directed Postoperative Activity Restriction | Postoperative activity restrictions self-determined (parent/guardian and/or patient). Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ages were collected from children only. Baseline data was not collected for parents/guardians.
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| ID | Title | Description |
|---|---|---|
| BG000 | Physician-directed Postoperative Activity Restriction | Postoperative activity restrictions prescribed by physician. Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. |
| BG001 | Self-directed Postoperative Activity Restriction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Operative Outcomes - Clinical Complications | Number of child participants who developed post op complications | data analyzed only for child participants | Posted | Count of Participants | Participants | six weeks post op |
|
6 months post procedure
adverse event data not collected from parents
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physician-directed Postoperative Activity Restriction | Postoperative activity restrictions prescribed by physician. Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection requiring antibiotics | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Studzinski | Beaumont Hospitals | 2485512570 | diane.studzinski@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2021 | Jun 10, 2022 | Prot_SAP_000.pdf |
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Prospective, nonrandomized, parallel
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Number of parent/guardian who chose physician-directed post operative instructions |
| 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 | six weeks post op |
| Troy |
| Michigan |
| 44201 |
| United States |
Postoperative activity restrictions self-determined (parent/guardian and/or patient). Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Both children and parents completed satisfaction surveys. Satisfaction data available only for the n=106 who completed the post-op survey. | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Data analyzed for child participants with survey responses. | Posted | Mean | Standard Deviation | days | 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 | data analyzed only for parent/guardian participants | Posted | Count of Participants | Participants | 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 | data analyzed only for parent/guardian participants | Posted | Count of Participants | Participants | 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 | data analyzed for parents who reported taking time off in survey | Posted | Mean | Standard Deviation | days | six weeks post op |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Self-directed Postoperative Activity Restriction | Postoperative activity restrictions self-determined (parent/guardian and/or patient). Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. | 0 | 62 | 0 | 62 | 5 | 62 |
| anesthesia reaction | Surgical and medical procedures | Systematic Assessment |
|
| skin inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| drug rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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