Is Acute Appendicitis Still a Clinical Diagnosis?

September 8, 2020 updated by: Claus Anders Bertelsen, PhD, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Observational

Enrollment (Actual)

82000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claus Anders Bertelsen, PhD, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2000

Primary Completion (ACTUAL)

December 31, 2015

Study Completion (ACTUAL)

January 31, 2016

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (ACTUAL)

July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-DIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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