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MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC

Completed
Conditions
Acute Appendicitis
Interventions
Procedure: laparoscopic or open appendicectomy
Registration Number
NCT04615728
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Brief 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.

Detailed 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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
207
Inclusion Criteria
  • Patients aged 16 years old and above
  • Confirmed diagnosis of acute appendicitis
Exclusion Criteria
  • Patients aged less than 16 years old

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
COVID cohortlaparoscopic or open appendicectomyPatients recruited from 10th March 2020 to 5th July 2020
pre-COVID cohortlaparoscopic or open appendicectomyPatients recruited from 1st November 2019 to 9th March 2020
Primary Outcome Measures
NameTimeMethod
Mortalitywithin 90 days of a patient's initial presentation

Death secondary to acute appendicitis

Failure of primary proposed treatmentwithin 90 days of a patient's initial presentation

failure of conservative management and need to undergo surgery

Secondary Outcome Measures
NameTimeMethod
Re-attendancewithin 90 days of a patient's initial presentation

Re-attendance to hospital after patient's discharge whether planned or unplanned

Imagingwithin 90 days of a patient's initial presentation

imaging modality obtained and findings to confirm the diagnosis of acute appendicitis

Intra-operative findings during surgerywithin 90 days of a patient's initial presentation

Intra-operative findings of pus or free fluid during appendicectomy

length of staywithin 90 days of a patient's initial presentation

length of stay in hospital from admission date till discharge date or death

Trial Locations

Locations (1)

Addenbrooke's University Hospital

🇬🇧

Cambridge, Cambridgeshire, United Kingdom

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