DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Other: Diagnostic imaging; Other: Observation

• Registration Number: NCT02742402
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-19
• Primary Completion: 2020-04-09
• Study Completion: 2021-04-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diagnostic imaging	Diagnostic imaging	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.
Observation	Observation	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.

Primary Outcome Measures

Name	Time	Method
Appendicitis requiring surgery or other intervention	30 days from randomization

Secondary Outcome Measures

Name	Time	Method
Delayed appendicitis diagnosis	30 days from randomization	Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization
Appendicitis requiring surgery or other intervention	within 1 year after randomization
Number of re-admissions to emergency unit	1 year	Any reason for re-admission are accounted
Number of other clinically relevant findings	30 days from randomization	Findings unrelated to appendicitis
Number of diagnostic imaging studies needed	30 days from randomization and within 1 year after randomization	Number of abdominal ultrasound and abdominal computed tomography per patient
Time for decision	30 days from randomization	The time from randomization to either decision to operate in appendicitis patients or to discharge in non-appendicitis patients.
Complicated appendicitis	30 days from randomization	Perforated appendicitis or appendiceal abscess
Negative appendectomy	30 days from randomization	Laparoscopy done for suspected appendicitis, but patient does not have appendicitis
Number of patients requiring of gynecological consultation	30 days from randomization	Applicable only in female patients

Trial Locations

Locations (1)

Helsinki University Central Hospital, Meilahti Hospital; 🇫🇮 Helsinki, Finland