- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205681
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
Intervention / Treatment
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
-
-
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London, United Kingdom, NW1 2BU
- University College London Hospitals NHS Foundation Trust
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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
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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)
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Assessed on day 30 after the completion of the study
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Post-Operative Complications Rate
Time Frame: Within 30 post-operative days
|
Number of patients who had post-operative complications
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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
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Cecal Diseases
- Intraabdominal Infections
- COVID-19
- Appendicitis
Other Study ID Numbers
- NARCO2021
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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