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OpenTrials
Completed

NCT Number: NCT04477824

Is Acute Appendicitis Still a Clinical Diagnosis?

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.

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Key information

About this study

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?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Diagnostic imaging

Diagnostic Test

Ultrasonography, computerized tomography, magnetic resonance imaging

Primary outcomes

  1. Annual percentage use diagnostic imaging before appendectomy

    Time frame: 24 hours

    Annual percentage use of abdominal ultrasonography, abdominal computerized tomography (with or without contrast) and abdominal MRI 24 hours before appendectomy for appendicitis.

Secondary outcomes

  1. Differences in use of ultrasonography.

    Time frame: 24 hours

    Differences in use of ultrasonography between gender, age groups divided into decades and the five Danish administrative regions.

  2. Differences in use of abdominal computerized tomography (with or without contrast)

    Time frame: 24 hours

    Differences in use of abdominal computerized tomography (with or without contrast) between gender, age groups divided into decades and the five Danish administrative regions.

  3. Differences in use of magnetic resonance imaging

    Time frame: 24 hours

    Differences in use of magnetic resonance imaging between gender, age groups divided into decades and the five Danish administrative regions.

Sponsors and collaborators

Lead sponsor

Claus Anders Bertelsen, PhD, MD

Other

Registry information

Official study title

Is Acute Appendicitis Still a Clinical Diagnosis? Use of Preoperative Diagnostic Imaging Before Appendectomy in Denmark During 2000-15.

Important dates

Study start
2000
Primary completion
2015
Study completion
2016
First posted
Jul 20, 2020
Registry last updated
Sep 9, 2020

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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