Clinical trial NCT02742402: DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis
Official title: DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appendicitis requiring surgery or other intervention
timeFrame: 30 days from randomization
Secondary outcomes:
measure: Complicated appendicitis
timeFrame: 30 days from randomization
measure: Delayed appendicitis diagnosis
timeFrame: 30 days from randomization
measure: Number of diagnostic imaging studies needed
timeFrame: 30 days from randomization and within 1 year after randomization
measure: Appendicitis requiring surgery or other intervention
timeFrame: within 1 year after randomization
measure: Negative appendectomy
timeFrame: 30 days from randomization
measure: Number of re-admissions to emergency unit
timeFrame: 1 year
measure: Number of other clinically relevant findings
timeFrame: 30 days from randomization
measure: Number of patients requiring of gynecological consultation
timeFrame: 30 days from randomization
measure: Time for decision
timeFrame: 30 days from randomization
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Meilahti Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Panu J Mentula, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114.
citation: Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120.