Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04615728 |
| Other study ID # |
PRN8996 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
October 6, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Cambridge University Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
During the Covid-19 pandemic, non-operative management for acute appendicitis (AA) was
implemented in the UK. The aim of this study was to determine the efficacy and outcomes of
conservative versus surgical management of AA during the pandemic.
Description:
This prospective observational cohort study was conducted in a single UK tertiary referral
centre and was registered locally as a clinical audit. Patients included in this study were
adults (≥16 years) with a diagnosis of acute appendicitis made clinically and/or
radiologically in our hospital. Patients presented sequentially to the emergency department,
and subsequently were referred to the emergency surgical service for further management. The
data collection periods were between 1st November 2019 and 10th March 2020 ('the pre-COVID
period') and 10th March 2020 to 5th July 2020 ('COVID period'). The start of the COVID period
was determined as the day of our hospital pandemic policy introduction, following the
identification of the first SARS-CoV-2 positive patient at our site.
Data were collected retrospectively for the pre-COVID period and prospectively during the
COVID pandemic using the electronic patient record (HYPERSPACE® Epic 2014 Version IU1, Epic
Systems Corporation, Verona, WI, USA). Data collected included patient demographics,
radiology reports, timings of consultations, operative records, post-operative care,
post-operative complications, re-operation rate, length of hospital stay (LOS), histology
results, re-attendance to hospital and mortality within 90 days of the initial presentation.
Study participants were scored using the Alvarado score (9), Appendicitis inflammatory
response (AIR) score (10), the Adult appendicitis score (AAS) (11), American Society of
Anaesthesiologists (ASA) physical status classification (12) and Rockwood Clinical Frailty
Scale (13) based on their initial presentation history and investigations, as previously
described in the literature. Conservative management was determined as the use of antibiotics
only (i.e. an intervention was not offered at initial consultation). Interventional radiology
(IR) guided drain insertion refers to CT or ultrasound (US) guided insertion of an
intra-abdominal drain. Time to theatre was calculated in hours from the admission time to the
start of the operation. Operative time was calculated in minutes from skin incision to the
end of skin closure. Time of day when the procedure was performed was determined by the start
time of the operation, with those starting after 17:00 until the following day at 08:00
classified to have been performed out of hours.
Operative details were recorded based on the operating surgeon's documentation. Conversion
from a laparoscopic to open approach was determined as additional incisions performed either
in the right iliac fossa or midline laparotomy. The level of the surgeon was determined based
on the years of practice post-qualification (Junior Trainee; Senior Trainee; Consultant).
Critical care admission was determined if the patient was cared for in a Level 2 (high
dependency unit) or a Level 3 care (intensive care unit) setting. Re-attendance referred to
any patient re-presenting following their initial admission. This study has been reported in
line with the STROCSS criteria (14).
