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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05205681
• Other study ID #: NARCO2021
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• COVID-19

Intervention

Diagnostic Test:
• Pre-operative imaging
Use of pre-operative imaging or the diagnosis of acute appendicitis

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Appendicectomy Rate (NAR)	Number of patients with final histology negative for acute appendicitis	Up to 3 weeks post-operatively (when final Histology is ready)
Secondary	Post-Operative Length of Stay	Post-operative length of hospital stay (from post-operative day 1)	Assessed on day 30 after the completion of the study
Secondary	Post-Operative Complications Rate	Number of patients who had post-operative complications	Within 30 post-operative days