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临床试验/NCT04145895
NCT04145895已完成不适用

Postoperative Activity Restrictions in Children

William Beaumont Hospitals3 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
3
主要终点
Post Operative Outcomes - Clinical Complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Post Operative Outcomes - Clinical Complications

时间窗: six weeks post op

Number of child participants who developed post op complications

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

时间窗: six weeks post op

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

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

时间窗: 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.

次要结局

  • Number of Parent/Guardians Choosing 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(six weeks post op)
  • Number of Parents/Guardians Choosing Self-directed Post Operative Instructions(six weeks post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavan Brahmamdam

Pediatric Surgeon

William Beaumont Hospitals

研究点 (3)

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