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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05205681
Other study ID # NARCO2021
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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