Feasability of Ambulatory Appendicectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The laparoscopic appendectomy is performed after the anesthesia consultation. The patient is monitored and replenished early in the UCA according to a standardized and computerized protocol. The return home is authorized by the confirmation of aptitude to the street by systematic consultation of a senior surgeon and an anesthetist. The surgical and anesthetic techniques remain the same as in traditional surgery, but the timing is organized for an outpatient treatment The follow-up of the child will be carried out as early as day 1 by the call of the UCA, then at day 8 during postoperative consultation and finally at day 30 post-operative per call.

Official Title
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Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years

Conditions
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Appendicitis Acute

Intervention / Treatment
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* Other: Ambulatory appendicectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory appendicectomy<br>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. | Other: Ambulatory appendicectomy<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of ambulatory care | 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 | day 8 after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain of the patient at home | To evaluate pain in the home, parents will be given a heterogeneous questionnaire in the form of a grid represented by a validated tool evaluating the management of the pain on the 3 post-operative days. PPMP Scale (Postoperative Pain Measure for Parents ) | 3 post-operative days | 
| rate of patients able to return home on the day of the intervention | pediatric postanesthetic discharge scoring system (Ped-PADSS) ≥ 9 / 10 | the day of the intervention at day 0 | 
| rate of consultations at Emergencies unit care before 8 days post operative | Evaluation through study of files on computer server of the Emergencies unit care before 8 days post operative | 8 days post operative | 
| Parent Satisfaction | Parent Satisfaction will be assessed through a questionnaire | 8 days post operative | 
| Patient Satisfaction | Patient Satisfaction will be assessed through a questionnaire | 8 days post operative | 
| number of overnight stays caused by the failures of ambulatory care | All hospitalization nights will be counted for patients in check up to day 8 in immediate postoperative | 8 days post operative | 
| re-admission rate at day 30 | The readmission rate will be defined as the percentage of patients rehospitalized at least once to 30 days for specific complications of the intervention or appendicitis. | 30 days post operative | 
| the rate of fallback due to specific complications of the intervention or appendicitis | The fallback rate is defined by the ratio of the number of patients transferred in conventional surgery to the total number of patients included in the study and operated | the day of the intervention at day 0 | 
| Parental satisfaction 1 day post operative | Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call | 1 day post operative | 
| Parental satisfaction 30 days post operative | Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call | 30 days post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendicitis Acute, AMBULATORY