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CompletedNCT02730585dCRPappendUpdated Sep 1, 2016

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

An observational study in Appendicitis, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2016-09-01.

Sponsored by University of Monastir · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
10 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Appendicitis

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Keywords

  • C-reactive protein
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In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 500 is above the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute appendicitis

    all patients admitted to our hospital with a clinically suspected acute appendicitis.

    Biological: C-reactive protein measurement

Interventions

  • BiologicalC-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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 days from patients inclusion

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Study locations

1 site
  • Emergency department of university hospital Fattouma Bourguiba of Monastir
    Monastir, 5000, Tunisia
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References and documents

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. PubMed 9279962 ↗
  • 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. PubMed 1941740 ↗
  • 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. PubMed 12564616 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02730585
Lead sponsor
University of Monastir
Responsible party
Pr. Semir Nouira (Professor, University of Monastir) — Principal investigator
First posted
Apr 6, 2016
Start date
Jan 2010
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Sep 1, 2016

Study contacts

Nouira Semir, Professor
principal investigator · University Hospital of Monastir

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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