Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-13 @ 7:25 PM
Study NCT ID:
NCT03186105
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasability of Ambulatory Appendicectomy
Sponsor:
Fondation Lenval
Organization:
Study Overview
Official Title:
Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: