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

Appendicitis Clinical Trial

— dCRPappend  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730585
• Other study ID #: 04/2016
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: August 31, 2016
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2016
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Emergency department of university hospital Fattouma Bourguiba of Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

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. — View Citation

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. — View Citation

Paajanen H, Mansikka A, Laato M, Ristamäki R, Pulkki K, Kostiainen S. Novel serum inflammatory markers in acute appendicitis. Scand J Clin Lab Invest. 2002;62(8):579-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No