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Diagnostic Performance of C Reactive Protein and Delta CRP in Acute Appendicitis (dCRPappend)

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ClinicalTrials.gov Identifier: NCT02730585
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Brief Summary:
The diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.

Condition or disease Intervention/treatment
Appendicitis Biological: C-reactive protein measurement

Detailed Description:

Acute appendicitis is the most common surgical emergency and the most common source of community-acquired intra-abdominal infections. The lack of accuracy in the diagnosis of acute appendicitis yields often to two types of outcomes: a delay in diagnosis leads to perforation and peritonitis in up to 15% of the cases and unnecessary appendectomy is associated with post-operative complications such as wound infection and adhesions. CRP is an acute phase protein that is often used by many surgeons as a diagnostic marker of acute appendicitis. During the evaluation of patients with possible appendicitis in the emergency department (ED), repeated physical examination of the abdomen may provide further information about the decision making. However, the role of repeated laboratory examinations is not proven.

The purpose of this study was to investigate whether repeated serum CRP measures could be useful to predict acute appendicitis, after 3 hours of observation, in comparison with the histopathological findings.


Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Performance of C-reactive Protein (CRP) Concentrations Variation (Delta CRP) in the Diagnosis of Acute Appendicitis in the ER
Study Start Date : January 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Acute appendicitis
all patients admitted to our hospital with a clinically suspected acute appendicitis.
Biological: C-reactive protein measurement
All patients included in this study underwent a blood sample analysis for C-reactive protein concentrations at admission and 3 hours later.



Primary Outcome Measures :
  1. Final diagnosis of acute appendicitis [ Time Frame: 15 days from patients inclusion ]
    The final diagnosis of acute appendicitis was based, in operated patients, on the results of the histologic examination of the excised appendix and, in non operated patients, on the absence of acute appendicitis at the 2 weeks follow-up visit.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting to the Fattouma Bourguiba University hospital with an equivocal diagnosis of acute appendicitis. The clinical suspiscion of appendicitis was made based on anamnestic and physical examination findings.
Criteria

Inclusion Criteria:

  • age > 8 year old
  • clinical suspicion of acute appendicitis including the presence of direct tenderness in the right lower quadrant, percussion and rebound tenderness, pyrexia, anorexia, nausea and vomiting.

Exclusion Criteria:

  • patients receiving anti coagulants
  • pregnant women
  • patients using antibiotics during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730585


Locations
Tunisia
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: Nouira Semir, Professor University Hospital of Monastir

Publications:
Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02730585     History of Changes
Other Study ID Numbers: 04/2016
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pr. Semir Nouira, University of Monastir:
C-reactive protein

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases