Appendicitis AcuteNCT03186105
Feasability of Ambulatory Appendicectomy
A study testing Ambulatory appendicectomy in people with Appendicitis Acute, run by Fondation Lenval at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Ambulatory appendicectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 2 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years
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.
Read the 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.
- Conditions
- Appendicitis Acute
- Being tested
- Ambulatory appendicectomy
- Keywords
- Appendicitis Acute, AMBULATORY
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory appendicectomyOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory appendicectomy | Experimental | 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. Receives: Other: Ambulatory appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 8 after intervention
Secondary outcomes (10)
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 )
Measured: 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
Measured: 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
Measured: 8 days post operative
Parent Satisfaction
Parent Satisfaction will be assessed through a questionnaire
Measured: 8 days post operative
Patient Satisfaction
Patient Satisfaction will be assessed through a questionnaire
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jun 2017
- Primary completion2 Jun 2019
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BASTIANI, MD, Principal investigator, Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186105
- Sponsor's protocol ID
- 16-HPNCL-05
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2017
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years
- ClinicalTrials.gov ID
- NCT03186105
- Acronym / sponsor ID
- 16-HPNCL-05
- Conditions
- Appendicitis Acute
- Keywords
- Appendicitis Acute, AMBULATORY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory appendicectomy | Experimental | Other: Ambulatory appendicectomyThe 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory appendicectomyThe 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 |
Primary outcome
Feasibility of ambulatory care
Time frame: 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
10 secondary outcomes
pain of the patient at home
Time frame: 3 post-operative days
rate of patients able to return home on the day of the intervention
Time frame: the day of the intervention at day 0
rate of consultations at Emergencies unit care before 8 days post operative
Time frame: 8 days post operative
Parent Satisfaction
Time frame: 8 days post operative
Patient Satisfaction
Time frame: 8 days post operative
number of overnight stays caused by the failures of ambulatory care
Time frame: 8 days post operative
re-admission rate at day 30
Time frame: 30 days post operative
the rate of fallback due to specific complications of the intervention or appendicitis
Time frame: the day of the intervention at day 0
Parental satisfaction 1 day post operative
Time frame: 1 day post operative
Parental satisfaction 30 days post operative
Time frame: 30 days post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BASTIANI, MD principal investigator
Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory appendicectomy in people with Appendicitis Acute, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of ambulatory care (time frame: day 8 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.