Appendicitis Clinical Trial
Official title:
The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic: a Retrospective Cohort Study
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 |
Verified date | February 2022 |
Source | University College London Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
University College London Hospitals |
United Kingdom,
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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