Clinical trial NCT04477824: Is Acute Appendicitis Still a Clinical Diagnosis?
Official title: Is Acute Appendicitis Still a Clinical Diagnosis? Use of Preoperative Diagnostic Imaging Before Appendectomy in Denmark During 2000-15.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: Appendicitis
Appendectomy
Preoperative diagnostic imaging
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 82000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Denmark with a diagnosis for appendicitis undergoing appendectomy during the same admission during the period 2000-15

Brief summary: This study aims to investigate the use of preoperative diagnostic imaging before appendectomy in Denmark and whether it has changed over time during the period from 2000-15. Secondly, the study aims to investigate regional, age and gender differences in the same setting.

Detailed description: Acute appendicitis is the most common cause of abdominal pain (1) and appendectomy is the most common emergency surgical procedure performed worldwide (2). During the last decades, there has been a paradigm shift in both diagnosis and treatment of appendicitis - surgical treatment has changed from open to laparoscopic appendectomy (3). Acute appendicitis has traditionally been a clinical diagnosis, but the use of preoperative diagnostic imaging has, in some countries, increased dramatically (4). The use of computed tomography (CT) before appendectomy is in the United States up to 90%, in England 13% and in Holland almost all patients undergo ultrasound and/or CT before appendectomy (1).

The use of antibiotics can be successful in the treatment of uncomplicated appendicitis verified on CT, and the use of CT has significantly lowered the negative appendectomy rate compared to clinical evaluation only (1). But the use of CT is inevitably inducing radiation and increasing lifetime risk of cancer - especially in younger patients who most frequently present with acute appendicitis (1,5). It is estimated that CT of the abdominal region can avoid 12 negative appendectomies but at the cost of one cancer death due to radiation (5). In Denmark surgery is still the only treatment for appendicitis, but how is appendicitis diagnosed? Is acute appendicitis still a clinical diagnosis?

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis for appendicitis undergoing appendectomy during the same admission during the period 2000-15

Exclusion Criteria:

* None

Primary outcomes:
measure: Annual percentage use diagnostic imaging before appendectomy
timeFrame: 24 hours
Secondary outcomes:
measure: Differences in use of ultrasonography.
timeFrame: 24 hours
measure: Differences in use of abdominal computerized tomography (with or without contrast)
timeFrame: 24 hours
measure: Differences in use of magnetic resonance imaging
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Nordsjaellands Hospital
name: Claus A Bertelsen, Phd
role: STUDY_CHAIR
References:
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citation: Sallinen V, Akl EA, You JJ, Agarwal A, Shoucair S, Vandvik PO, Agoritsas T, Heels-Ansdell D, Guyatt GH, Tikkinen KA. Meta-analysis of antibiotics versus appendicectomy for non-perforated acute appendicitis. Br J Surg. 2016 May;103(6):656-667. doi: 10.1002/bjs.10147. Epub 2016 Mar 17.