Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of ambulatory care
研究概览
简要总结
The investigators will conduct a monocentric prospective preliminary study evaluating the feasibility of appendectomy for simple acute appendicitis in a cohort of 6-17 year-old children presenting to the emergency department of the Hôpital Pédiatrique de Nice CHU-Lenval (Lenval Childre Hospital, Nice) on a Period of 1 year.
详细描述
Acute appendicitis represents the first visceral surgical emergency of the child in terms of frequency, resulting in hospitalization, hospitalization and family costs, as well as an alteration in family dynamics.
Reducing the duration of hospitalization and allowing the child to return more quickly to his usual environment would not only reduce the risks of nosocomial infections and the workload of medical and paramedical teams but would reduce the emotional burden for the child, In addition to its consequences in terms of professional disorganization induced in the parents by the hospitalization of their child. Ambulatory hospitalization would also reduce the cost of this pathology.
In the context of ambulatory surgery, the patient's journey from admission to hospital must be perfectly codified; The novelty of this study lies in the fact of applying this mode of hospitalization to emergency surgery.
Once the consultation for abdominal pain by an emergency pediatrician carried out, the diagnostic orientation is confirmed by a visceral pediatric surgeon who performs a biological check-up and an abdominal ultrasound. After confirmation of eligibility for ambulatory care according to national recommendations and informed consent, the child is - according to the time of care and the clinical condition of the patient - immediately hospitalized in the unit (UCA) be allowed to return to his home with reconviction in the ambulatory surgery unit the next morning, at the opening of the service, on an empty stomach.
The abdominal ultrasound confirms the orientation and the diagnosis of acute appendicitis simple is posed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boy or girl
- •Subjects aged 6 to 17 years (Children under 6 years of age with a table of acute appendicitis will not be included in the high probability of complicated acute appendicitis in these young children who are often rapidly changing pathology or delayed diagnosis Patients over 17 years of age are usually referred to adult hospitals and will not be included)
- •Surgical indication of appendectomy under laparoscopy for simple acute appendicitis according to clinico-biological criteria (Appendix 6).
- •Ambulatory eligibility according to the criteria usually defined
- •Dosage of negative bHCG (exclusion of pregnancy)
- •Parents and children able to understand the study and having signed informed consent
- •Possibility of organizing childcare immediately at home
- •Subjects and holders of parental authority who have given their informed and written consent
- •Subjects affiliated to Social Security system
排除标准
- •Patients who had spent an overnight stay in hospital prior to surgery and therefore could not meet the ambulatory criteria.
- •An ASA score higher than III
- •Impossibility of ambulatory surgery due to a residence outside the coverage area defined by the surgical and ambulatory anesthesia service, the impossibility of being transported after returning home, the absence of parents Child after discharge from hospital
- •Contra-indication to the practice of an appendectomy under laparoscopy
研究组 & 干预措施
Ambulatory appendicectomy
The intervention consist of an ambulatory care by appendicectomy of the acute appendicitis. The normal care is an appendicectomy and an hospitalisation during 2 or 3 days.
干预措施: Ambulatory appendicectomy (Other)
结局指标
主要结局
Feasibility of ambulatory care
时间窗: day 8 after intervention
Feasibility is defined as the association of the return to the patient's home within the twelve hours of the intervention and the absence of re-hospitalization or recourse to town medicine before the postoperative consultation at day 8
次要结局
- pain of the patient at home(3 post-operative days)
- Parent Satisfaction(8 days post operative)
- rate of patients able to return home on the day of the intervention(the day of the intervention at day 0)
- re-admission rate at day 30(30 days post operative)
- Parental satisfaction 30 days post operative(30 days post operative)
- rate of consultations at Emergencies unit care before 8 days post operative(8 days post operative)
- the rate of fallback due to specific complications of the intervention or appendicitis(the day of the intervention at day 0)
- Parental satisfaction 1 day post operative(1 day post operative)
- Patient Satisfaction(8 days post operative)
- number of overnight stays caused by the failures of ambulatory care(8 days post operative)