NCT04214340

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

4 months

First QC Date

December 27, 2019

Last Update Submit

December 28, 2019

Conditions

Keywords

laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical practices in the management of adults and pediatrics patients with appendicitis

    Rate of laparoscopic surgery

    6 months

Interventions

Study of the management and follow-up of patients presenting with appendicitis in France.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients admitted for appendicitis in participating centers
  • informed

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26460662BACKGROUND
  • 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.

    PMID: 27403670BACKGROUND
  • 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.

    PMID: 28286544BACKGROUND
  • 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.

    PMID: 30243444BACKGROUND

MeSH Terms

Conditions

AppendicitisPeritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPeritoneal Diseases

Study Officials

  • catherine ARVIEUX, MD, PHD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 2, 2020

Study Start

March 1, 2016

Primary Completion

June 30, 2016

Study Completion

March 23, 2017

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share