AppendicitisPMSIAppNCT02894086
A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014
An observational study of Appendicitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- database.
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 13 Dec 2017
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on for acute appendicitis between December 2013 and December 2014
Who may be able to join
- Medical criteria:
- Patients operated on for acute appendicitis between December 2013 and December 2014
- Sociodemographic criteria:
- Adult patients (aged between 18 and 75, inclusive)
- Social security coverage
Who cannot join
- Sociodemographic criteria:
- Patients under the age of 18
- Pregnancy or breastfeeding
- Legal guardianship or incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.
Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.
Read more
The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.
The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.
- Conditions
- Appendicitis
- Being tested
- database.
- Keywords
- acute appendicitis, ambulatory appendicectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
database.Other
database
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the population of patients having been hospitalized for less than 24 hours.
The ICD-10 diagnostic codes for acute appendicitis, stored in the PMSI.
Measured: during 1 year (from december 2013 to december 2014)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start13 Dec 2017
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Why it stopped: Investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REGIMBEAU Jean-Marc, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894086
- Sponsor's protocol ID
- RNI2015-35 Pr-REGIMBEAU-2
- Acronym
- PMSIApp
- Status last verified
- Jul 2020
- First submitted
- 5 Sep 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014
- ClinicalTrials.gov ID
- NCT02894086
- Acronym / sponsor ID
- PMSIApp / RNI2015-35 Pr-REGIMBEAU-2
- Conditions
- Appendicitis
- Keywords
- acute appendicitis, ambulatory appendicectomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.
Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.
The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization <24 hours) or ambulatory care (hospitalization <12 hours) have yet to be identified.
The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on for acute appendicitis between December 2013 and December 2014
Key inclusion criteria (5 listed)
- Patients operated on for acute appendicitis between December 2013 and December 2014
- Adult patients (aged between 18 and 75, inclusive)
- Social security coverage
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Pregnancy or breastfeeding
- Legal guardianship or incarceration
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 |
|---|---|---|
| database.database | Other | – |
Primary outcome
identify the population of patients having been hospitalized for less than 24 hours.
Time frame: during 1 year (from december 2013 to december 2014)
The ICD-10 diagnostic codes for acute appendicitis, stored in the PMSI.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
REGIMBEAU Jean-Marc, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Centre Hospitalier Universitaire, Amiens 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 5 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
identify the population of patients having been hospitalized for less than 24 hours. (time frame: during 1 year (from december 2013 to december 2014)). 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 15 Jul 2020.