Helsinki University Central Hospital, Meilahti Hospital
Helsinki, 00029, Finland
NCT Number: NCT02742402
The aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. The hypothesis is that resolving appendicitis is common in these patients. Thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Helsinki, 00029, Finland
For the study equivocal appendicitis is defined as clinical suspicion of appendicitis with Adult Appendicitis Score between 11 and 15. The estimated prevalence of appendicitis in such patients is around 50%.
Diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound.
In observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of Adult Appendicitis Score. Patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. Laparoscopy is done without imaging in patients with high score (16 or higher). Antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abdominal ultrasound, followed by abdominal computed tomography when necessary
Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.
Time frame: 30 days from randomization
Time frame: 30 days from randomization
Perforated appendicitis or appendiceal abscess
Time frame: 30 days from randomization
Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization
Time frame: 30 days from randomization and within 1 year after randomization
Number of abdominal ultrasound and abdominal computed tomography per patient
Time frame: within 1 year after randomization
Time frame: 30 days from randomization
Laparoscopy done for suspected appendicitis, but patient does not have appendicitis
Time frame: 1 year
Any reason for re-admission are accounted
Time frame: 30 days from randomization
Findings unrelated to appendicitis
Time frame: 30 days from randomization
Applicable only in female patients
Time frame: 30 days from randomization
The time from randomization to either decision to operate in appendicitis patients or to discharge in non-appendicitis patients.
Helsinki University Central Hospital
Other
DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial
Acronym: DIAMOND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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