NCT02304653

Brief Summary

Aim: To investigate if the results of CRP and leucocytes had any positive or negative influence on the surgeon's decision-making when handling patients with suspected AA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

November 24, 2014

Last Update Submit

April 30, 2015

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Change in diagnosis

    Two hours

Interventions

Clinical descision makingOTHER

Chage in diagnosis before and after the presentation of the reults of CRP and Leucocytes

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute abdominal pain with the suspicion of acute appendicitis

Acutae abdominal pain Suspect for acute appendicites

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital, surgical department A

Odense C, DK-5000, Denmark

Location

Related Publications (2)

  • Tind S, Qvist N. Acute Appendicitis: A Weak Concordance Between Perioperative Diagnosis, Pathology and Peritoneal Fluid Cultivation. World J Surg. 2017 Jan;41(1):70-74. doi: 10.1007/s00268-016-3686-8.

    PMID: 27541029DERIVED

  • Tind S, Lassen AT, Zimmerman-Nielsen E, Qvist N. C-reactive protein and white blood cell count do not improve clinical decision-making in acute appendicitis. Dan Med J. 2015 Dec;62(12):A5167.

    PMID: 26621395DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Niels Qvist, Professor

    Head of surgical eserach unit

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 2, 2014

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

DK(1)