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NCT Number: NCT02742402

DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Meilahti Hospital

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic imaging

Other

Abdominal ultrasound, followed by abdominal computed tomography when necessary

observation

Other

Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.

Primary outcomes

  1. Appendicitis requiring surgery or other intervention

    Time frame: 30 days from randomization

Secondary outcomes

  1. Complicated appendicitis

    Time frame: 30 days from randomization

    Perforated appendicitis or appendiceal abscess

  2. Delayed appendicitis diagnosis

    Time frame: 30 days from randomization

    Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization

  3. Number of diagnostic imaging studies needed

    Time frame: 30 days from randomization and within 1 year after randomization

    Number of abdominal ultrasound and abdominal computed tomography per patient

  4. Appendicitis requiring surgery or other intervention

    Time frame: within 1 year after randomization

  5. Negative appendectomy

    Time frame: 30 days from randomization

    Laparoscopy done for suspected appendicitis, but patient does not have appendicitis

  6. Number of re-admissions to emergency unit

    Time frame: 1 year

    Any reason for re-admission are accounted

  7. Number of other clinically relevant findings

    Time frame: 30 days from randomization

    Findings unrelated to appendicitis

  8. Number of patients requiring of gynecological consultation

    Time frame: 30 days from randomization

    Applicable only in female patients

  9. Time for decision

    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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial

Acronym: DIAMOND

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 19, 2016
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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