Clinical Trial: Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging
Brief Summary:
Patients with acute abdominal pain and suspicion of appendicitis are common. The management of these patients is controversial with large variations between hospitals. The clinical diagnosis is regarded as insufficient necessitating the use of diagnostic techniques like ultrasound, computerized tomography and diagnostic laparoscopy. However, the role of these diagnostic techniques is not clear.
This aim of this prospective interventional study is to analyze the impact of the implementation of a clinical score to improve the clinical diagnosis and to serve as a basis for a structured management of these patients by comparison of the results after the implementation of the score with that of a baseline period. In the group of patients with indeterminate diagnosis according to the clinical score, the value of diagnostic imaging will be evaluated and compared with a period of in-hospital observation by randomization. The hypothesis is that a clinical score will decrease the use of unnecessary diagnostic imaging and unnecessary admissions to hospital for observation.
Detailed Summary:
Patients with suspected appendicitis are common. Evidence based and efficient guidelines for the management of these patients are lacking. Small changes in the management of these patients may have important consequences for the health system.
The diagnosis is difficult and in up to 25% of operations a non-inflamed appendix is found. The management of patients with an equivocal diagnosis is controversial. Some advocate early surgical exploration to avoid increased morbidity following perforation, with an associated high frequency of negative explorations as an acceptable trade off. Others propose active observation, which gives an improved diagnostic accuracy without increasing the number of perforations. Early detection and treatment is more important in advanced appendicitis, which is associated with a higher morbidity and mortality, whereas spontaneous resolution is a possibility in phlegmonous appendicitis.
The management is based on the disease history, the clinical presentation and laboratory examinations. We have shown that the inflammatory variables have higher discriminating capacity than is previously thought, especially in advanced appendicitis. There are also new inflammatory markers with unknown diagnostic value. The clinical diagnosis is a subjective art, that can be made more objective by the use of a clinical scoring system. This suggests that the clinical diagnosis can be improved.
Imaging techniques, such as ultrasound (US) and Computerised Tomography (CT) have shown high sensitivity and specificity in prospective studies in specialised centres but the results in everyday use are less encouraging. Some results suggests that unselective use of imaging will lead to an increased number of appendectomies because of an increased detection of appendicitis cases
Sponsor: Ryhov County Hospital
Current Primary Outcome: Proportion of negative appendectomies [ Time Frame: During the hospital admission ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Proportion of unnecessary admissions to hospital [ Time Frame: During the contact with the emergency department ]
Original Secondary Outcome: Same as current
Information By: Ryhov County Hospital
Dates:
Date Received: September 1, 2009
Date Started: September 2009
Date Completion:
Last Updated: May 4, 2015
Last Verified: May 2015
