- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214340
Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort (APPEA)
December 28, 2019 updated by: Pr Catherine Arvieux, Association Francaise de Chirurgie
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
2285
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admited in participating centers for acute appendicitis between 2016/03/01 and 2016/06/30
Description
Inclusion Criteria:
- patients admitted for appendicitis in participating centers
- informed
Exclusion Criteria:
- patient's (or parent's for children) opposition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical practices in the management of adults and pediatrics patients with appendicitis
Time Frame: 6 months
|
Rate of laparoscopic surgery
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: catherine ARVIEUX, MD, PHD, CHU Grenoble Alpes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum In: Lancet. 2017 Oct 14;390(10104):1736.
- Mak 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.
- Teixeira 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.
- Wagner 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
March 23, 2017
Study Registration Dates
First Submitted
December 27, 2019
First Submitted That Met QC Criteria
December 28, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 28, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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