Clinical trial NCT03186105: Feasability of Ambulatory Appendicectomy
Official title: Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis Acute
Keywords: Appendicitis Acute
AMBULATORY
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of ambulatory care
timeFrame: day 8 after intervention
Secondary outcomes:
measure: pain of the patient at home
timeFrame: 3 post-operative days
measure: rate of patients able to return home on the day of the intervention
timeFrame: the day of the intervention at day 0
measure: rate of consultations at Emergencies unit care before 8 days post operative
timeFrame: 8 days post operative
measure: Parent Satisfaction
timeFrame: 8 days post operative
measure: Patient Satisfaction
timeFrame: 8 days post operative
measure: number of overnight stays caused by the failures of ambulatory care
timeFrame: 8 days post operative
measure: re-admission rate at day 30
timeFrame: 30 days post operative
measure: the rate of fallback due to specific complications of the intervention or appendicitis
timeFrame: the day of the intervention at day 0
measure: Parental satisfaction 1 day post operative
timeFrame: 1 day post operative
measure: Parental satisfaction 30 days post operative
timeFrame: 30 days post operative
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-LENVAL
Study officials:
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Florence BASTIANI, MD
role: PRINCIPAL_INVESTIGATOR
References: