DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis (DIAMOND)

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Appendicitis

Treatments: Other: Observation; Other: Diagnostic imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02742402

HUS/95/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical suspicion of acute appendicitis
• Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.

Exclusion criteria

• C-reactive protein >99 mg/l
• Time from symptom onset over 24 hours
• Pregnancy
• Antibiotics given within last 24 hours
• Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation
• Missing written informed consent
• Patient randomized earlier to the study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

Observation

Experimental group

Description:

Clinical follow-up for at least 6-8 hours, after follow-up repeated laboratory tests and repeated clinical examination is done. Adult Appendicitis Score is calculated after observation to determine further actions. Observation is continued in patients with decreasing score. Patients with the same or higher score undergo diagnostic imaging (score 11-15) or laparoscopy (score 16 or higher). Diagnostic imaging is abdominal ultrasound first and if the result is inconclusive or negative for appendicitis abdominal computed tomography is done. Laparoscopic appendectomy is done for those patients with appendicitis in diagnostic imaging.

Treatment:

Other: Observation

Diagnostic imaging

Active Comparator group

Description:

Patients undergo abdominal ultrasound and if the result is inconclusive or negative for appendicitis patients will have abdominal computed tomography. Laparoscopic appendectomy is done for patients with appendicitis in diagnostic imaging.

Treatment:

Other: Diagnostic imaging