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Feasability of Ambulatory Appendicectomy

Primary Purpose

Appendicitis Acute

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ambulatory appendicectomy
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Appendicitis Acute focused on measuring Appendicitis Acute, AMBULATORY

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Pédiatriques de Nice CHU-LENVAL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ambulatory appendicectomy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 )
rate of patients able to return home on the day of the intervention
pediatric postanesthetic discharge scoring system (Ped-PADSS) ≥ 9 / 10
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
Parent Satisfaction
Parent Satisfaction will be assessed through a questionnaire
Patient Satisfaction
Patient Satisfaction will be assessed through a questionnaire
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
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.
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
Parental satisfaction 1 day post operative
Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call
Parental satisfaction 30 days post operative
Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call

Full Information

First Posted
June 12, 2017
Last Updated
July 18, 2019
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT03186105
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 2, 2019 (Actual)
Study Completion Date
June 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
Appendicitis Acute, AMBULATORY

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory appendicectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ambulatory appendicectomy
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Feasibility of ambulatory care
Description
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
Time Frame
day 8 after intervention
Secondary Outcome Measure Information:
Title
pain of the patient at home
Description
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 )
Time Frame
3 post-operative days
Title
rate of patients able to return home on the day of the intervention
Description
pediatric postanesthetic discharge scoring system (Ped-PADSS) ≥ 9 / 10
Time Frame
the day of the intervention at day 0
Title
rate of consultations at Emergencies unit care before 8 days post operative
Description
Evaluation through study of files on computer server of the Emergencies unit care before 8 days post operative
Time Frame
8 days post operative
Title
Parent Satisfaction
Description
Parent Satisfaction will be assessed through a questionnaire
Time Frame
8 days post operative
Title
Patient Satisfaction
Description
Patient Satisfaction will be assessed through a questionnaire
Time Frame
8 days post operative
Title
number of overnight stays caused by the failures of ambulatory care
Description
All hospitalization nights will be counted for patients in check up to day 8 in immediate postoperative
Time Frame
8 days post operative
Title
re-admission rate at day 30
Description
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.
Time Frame
30 days post operative
Title
the rate of fallback due to specific complications of the intervention or appendicitis
Description
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
Time Frame
the day of the intervention at day 0
Title
Parental satisfaction 1 day post operative
Description
Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call
Time Frame
1 day post operative
Title
Parental satisfaction 30 days post operative
Description
Parent Satisfaction will be assessed by a Likert scale which will be proposed during a telephone call
Time Frame
30 days post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence BASTIANI, MD
Organizational Affiliation
Hôpitaux Pédiatriques de Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Pédiatriques de Nice CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasability of Ambulatory Appendicectomy

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