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

Evaluation of the Performance of C-reactive Protein (CRP) Concentrations Variation (Delta CRP) in the Diagnosis of Acute Appendicitis in the ER

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: 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
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Emergency department of university hospital Fattouma Bourguiba of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final diagnosis of acute appendicitis	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.	15 days from patients inclusion

Collaborators and Investigators

• Sponsor: University of Monastir

Publications and helpful links

General Publications

• Hallan S, Asberg A. The accuracy of C-reactive protein in diagnosing acute appendicitis--a meta-analysis. Scand J Clin Lab Invest. 1997 Aug;57(5):373-80. doi: 10.3109/00365519709084584.
• Davies AH, Bernau F, Salisbury A, Souter RG. C-reactive protein in right iliac fossa pain. J R Coll Surg Edinb. 1991 Aug;36(4):242-4.
• Paajanen H, Mansikka A, Laato M, Ristamaki R, Pulkki K, Kostiainen S. Novel serum inflammatory markers in acute appendicitis. Scand J Clin Lab Invest. 2002;62(8):579-84. doi: 10.1080/003655102764654312.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (ESTIMATE): April 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: C-reactive protein
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 04/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED