NCT02894086

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 13, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

September 5, 2016

Last Update Submit

July 13, 2020

Conditions

Keywords

acute appendicitisambulatory appendicectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    during 1 year (from december 2013 to december 2014)

Interventions

database

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated on for acute appendicitis between December 2013 and December 2014

You may qualify if:

  • 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

You may not qualify if:

  • Sociodemographic criteria:
  • Patients under the age of 18
  • Pregnancy or breastfeeding
  • Legal guardianship or incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Database Management Systems

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Management Information SystemsOrganization and AdministrationHealth Services Administration

Study Officials

  • REGIMBEAU Jean-Marc, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

December 13, 2017

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations