Appendicitis in Adults and Children in France-A Prospecti... | NCT04214340

Studies
Appendicitis in Adults and Children in France-A Prospective Study by the French Surgical Association Multicenter Cohort

NCT04214340

Sponsor

Association Francaise de Chirurgie

Status

Completed

Last Update Posted

Jan 2, 2020Actual

Enrollment

2,285Actual

Phase

Not provided

Conditions

Appendicitis Acute
Peritonitis

Interventions

evaluation of practices

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Mar 23, 2017Actual

First Submitted Date

Dec 27, 2019

First Submission Date that Met QC Criteria

Dec 28, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2019

Last Update Posted Date

Jan 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pr Catherine Arvieux, Professor, Association Francaise de ChirurgiePrincipal Investigator

Lead Sponsor

Association Francaise de ChirurgieOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,285Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
evaluation of practices	Other	Study of the management and follow-up of patients presenting with appendicitis in France.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical practices in the management of adults and pediatrics patients with appendicitis	Rate of laparoscopic surgery	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted for appendicitis in participating centers
informed

Exclusion Criteria:

patient's (or parent's for children) opposition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admited in participating centers for acute appendicitis between 2016/03/01 and 2016/06/30

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
catherine ARVIEUX, MD, PHD	CHU Grenoble Alpes	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26460662	Background	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.
27403670	Background	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.

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

ID	Term
D001064	Appendicitis
D010538	Peritonitis