The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic

February 2, 2022 updated by: Dr Gerardo Perrotta, University College London Hospitals

The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic: a Retrospective Cohort Study

This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. The study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020. The final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

313

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, NW1 2BU
        • University College London Hospitals NHS Foundation Trust

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients operated at a tertiary centre

Description

Inclusion Criteria:

  • Patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis
  • Patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis

Exclusion Criteria:

  • Patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon
  • Patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours
  • Patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pandemic Group
All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021
Use of pre-operative imaging or the diagnosis of acute appendicitis
Control Group
All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020
Use of pre-operative imaging or the diagnosis of acute appendicitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Appendicectomy Rate (NAR)
Time Frame: Up to 3 weeks post-operatively (when final Histology is ready)
Number of patients with final histology negative for acute appendicitis
Up to 3 weeks post-operatively (when final Histology is ready)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Operative Length of Stay
Time Frame: Assessed on day 30 after the completion of the study
Post-operative length of hospital stay (from post-operative day 1)
Assessed on day 30 after the completion of the study
Post-Operative Complications Rate
Time Frame: Within 30 post-operative days
Number of patients who had post-operative complications
Within 30 post-operative days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gerardo Perrotta, MD, University College London Hospitals

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)

December 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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