NCT05205681

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 7, 2022

Last Update Submit

February 2, 2022

Conditions

Appendicitis

Keywords

appendicitisCOVID-19negative appendicectomy ratecomputer tomographyultrasonographypre-operative imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Post-Operative Length of Stay

    Assessed on day 30 after the completion of the study

  • Post-Operative Complications Rate

    Within 30 post-operative days

Study Arms (2)

Pandemic Group

All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021

Diagnostic Test: Pre-operative imaging

Control Group

All patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020

Diagnostic Test: Pre-operative imaging

Interventions

Pre-operative imagingDIAGNOSTIC_TEST

Use of pre-operative imaging or the diagnosis of acute appendicitis

Control GroupPandemic Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients operated at a tertiary centre

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

  • Perrotta G, Geropoulos G, Bhan C. The role of imaging in the diagnosis of acute appendicitis during the COVID-19 pandemic: a retrospective cohort study. Updates Surg. 2023 Jan;75(1):205-208. doi: 10.1007/s13304-022-01426-y. Epub 2022 Nov 24.

    PMID: 36422811DERIVED

MeSH Terms

Conditions

AppendicitisCOVID-19

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gerardo Perrotta, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trust Grade Doctor in General Surgery

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 25, 2022

Study Start

December 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)