NCT01953289

Brief Summary

The purpose of this study is to evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis. In addition predictors of positive free fluid cultures will be analyzed.

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 Jul 2012

Typical duration for all trials

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

2.4 years

First QC Date

February 19, 2013

Last Update Submit

July 3, 2015

Conditions

Keywords

AppendicitisFree fluid

Outcome Measures

Primary Outcomes (1)

  • To evaluate the frequency of positive free fluid cultures in both perforated and non-perforated appendicitis

    In case of free peritoneal fluid, a sample will be aspirated and sent for microbiology.

    24 hours

Study Arms (1)

Appendicitis

Free fluid in perforated or non-perforated appendicitis

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with perforated or non-perforated appendicitis

You may qualify if:

  • Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 - 90y

You may not qualify if:

  • Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age \< 6 and \> 90y

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinics Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • André JL D'Hoore, PhD

    university Clinics Gasthuisberg department of abdominal surgery

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

February 19, 2013

First Posted

September 30, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations