Appendicitis AcuteAPPEANCT04214340
Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort
An observational study of Appendicitis Acute and Peritonitis, run by Association Francaise de Chirurgie.
Trial summary
Acute appendicitis still represents a surgical challenge, despite profound changes in practice in recent decades. The objective of this study was comprehensively document current surgical practices aimed at improving the management and follow-up of pediatrics and adults patients presenting with appendicitis in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis Acute, Peritonitis
- What is being tested?
- evaluation of practices
- How many people
- 2,285 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 23 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admited in participating centers for acute appendicitis between 2016/03/01 and 2016/06/30
Who may be able to join
- patients admitted for appendicitis in participating centers
- informed
Who cannot join
- patient's (or parent's for children) opposition
About this study
Official title: Current Management of Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort (APPEA)
Acute appendicitis still represents a surgical challenge, despite profound changes in practice in recent decades. The objective of this study was comprehensively document current surgical practices aimed at improving the management and follow-up of pediatrics and adults patients presenting with appendicitis in France.
Read the detailed description
The APPEA series is a national multicentric prospective cohort that included children and adults in France with acute appendicitis presenting between March 1st and June 30th, 2016. Data included demographic characteristics, medical history, symptoms, biology, radiology, treatments given during hospitalization, the modalities of the intervention, and any complications during a follow-up period of 6 months.
- Conditions
- Appendicitis Acute, Peritonitis
- Being tested
- evaluation of practices
- Keywords
- laparoscopic surgery
- Medical subject headings
- Appendicitis, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of practicesOther
Study of the management and follow-up of patients presenting with appendicitis in France.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical practices in the management of adults and pediatrics patients with appendicitis
Rate of laparoscopic surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Mar 2016
- Primary completion30 Jun 2016
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise de Chirurgie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Catherine Arvieux, Association Francaise de Chirurgie
- Investigators
- catherine ARVIEUX, MD, PHD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214340
- Sponsor's protocol ID
- AFC
- Acronym
- APPEA
- Status last verified
- Dec 2019
- First submitted
- 27 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
PubMed 26460662Mak GZ, Loeff DS. Paradigm Shifts in the Treatment of Appendicitis. Pediatr Ann. 2016 Jul 1;45(7):e235-40. doi: 10.3928/00904481-20160525-01.
PubMed 27403670Teixeira FJR Jr, Couto Netto SDD, Akaishi EH, Utiyama EM, Menegozzo CAM, Rocha MC. Acute appendicitis, inflammatory appendiceal mass and the risk of a hidden malignant tumor: a systematic review of the literature. World J Emerg Surg. 2017 Mar 9;12:12. doi: 10.1186/s13017-017-0122-9. eCollection 2017.
PubMed 28286544Wagner M, Tubre DJ, Asensio JA. Evolution and Current Trends in the Management of Acute Appendicitis. Surg Clin North Am. 2018 Oct;98(5):1005-1023. doi: 10.1016/j.suc.2018.05.006. Epub 2018 Jul 13.
PubMed 30243444
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Management of Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort (APPEA)
- ClinicalTrials.gov ID
- NCT04214340
- Acronym / sponsor ID
- APPEA / AFC
- Conditions
- Appendicitis Acute, Peritonitis
- Keywords
- laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,285 participants (actual)
- Lead sponsor
- Association Francaise de ChirurgieUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 2 Jan 2020 (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.
Acute appendicitis still represents a surgical challenge, despite profound changes in practice in recent decades. The objective of this study was comprehensively document current surgical practices aimed at improving the management and follow-up of pediatrics and adults patients presenting with appendicitis in France.
Detailed description
The APPEA series is a national multicentric prospective cohort that included children and adults in France with acute appendicitis presenting between March 1st and June 30th, 2016. Data included demographic characteristics, medical history, symptoms, biology, radiology, treatments given during hospitalization, the modalities of the intervention, and any complications during a follow-up period of 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admited in participating centers for acute appendicitis between 2016/03/01 and 2016/06/30
Key inclusion criteria (2 listed)
- patients admitted for appendicitis in participating centers
- informed
Key exclusion criteria (1 listed)
- patient's (or parent's for children) opposition
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 |
|---|---|---|
| evaluation of practicesStudy of the management and follow-up of patients presenting with appendicitis in France. | Other | – |
Primary outcome
Surgical practices in the management of adults and pediatrics patients with appendicitis
Time frame: 6 months
Rate of laparoscopic surgery
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 2 Jan 2020.
- Background: PubMed 26460662Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
- Background: PubMed 27403670Mak GZ, Loeff DS. Paradigm Shifts in the Treatment of Appendicitis. Pediatr Ann. 2016 Jul 1;45(7):e235-40. doi: 10.3928/00904481-20160525-01.
- Background: PubMed 28286544Teixeira FJR Jr, Couto Netto SDD, Akaishi EH, Utiyama EM, Menegozzo CAM, Rocha MC. Acute appendicitis, inflammatory appendiceal mass and the risk of a hidden malignant tumor: a systematic review of the literature. World J Emerg Surg. 2017 Mar 9;12:12. doi: 10.1186/s13017-017-0122-9. eCollection 2017.
- Background: PubMed 30243444Wagner M, Tubre DJ, Asensio JA. Evolution and Current Trends in the Management of Acute Appendicitis. Surg Clin North Am. 2018 Oct;98(5):1005-1023. doi: 10.1016/j.suc.2018.05.006. Epub 2018 Jul 13.
- Individual participant dataSharing planned: No
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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.
catherine ARVIEUX, MD, PHD principal investigator
CHU Grenoble Alpes
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute and Peritonitis, run by Association Francaise de Chirurgie.
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 2 inclusion and 1 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Surgical practices in the management of adults and pediatrics patients with appendicitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214340, which also lists 4 linked publications.
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 2 Jan 2020.