MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC (observational)

APPENDICITIS DURING THE COVID-19 PANDEMIC: TO OPERATE OR NOT TO OPERATE, THAT IS THE QUESTION: COHORT STUDY FROM A TERTIARY CENTRE

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: laparoscopic or open appendicectomy

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).

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrooke's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients included in this study were all 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.

Description

Inclusion Criteria:

• Patients aged 16 years old and above
• Confirmed diagnosis of acute appendicitis

Exclusion Criteria:

• Patients aged less than 16 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre-COVID cohort; Patients recruited from 1st November 2019 to 9th March 2020	Procedure: laparoscopic or open appendicectomy; Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection; Other Names: conservative antibiotic therapy
COVID cohort; Patients recruited from 10th March 2020 to 5th July 2020	Procedure: laparoscopic or open appendicectomy; Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection; Other Names: conservative antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death secondary to acute appendicitis	within 90 days of a patient's initial presentation
Failure of primary proposed treatment	failure of conservative management and need to undergo surgery	within 90 days of a patient's initial presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	length of stay in hospital from admission date till discharge date or death	within 90 days of a patient's initial presentation
Re-attendance	Re-attendance to hospital after patient's discharge whether planned or unplanned	within 90 days of a patient's initial presentation
Imaging	imaging modality obtained and findings to confirm the diagnosis of acute appendicitis	within 90 days of a patient's initial presentation
Intra-operative findings during surgery	Intra-operative findings of pus or free fluid during appendicectomy	within 90 days of a patient's initial presentation

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: R Antakia, A Xanthis, F Georgiades, V Hudson, J Ashcroft, S Rooney, AA Singh, JR O'Neill, N Fearnhead, RH Hardwick, RJ Davies, John M Bennett

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): July 5, 2020
• Study Completion (ACTUAL): October 6, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: acute appendicitis; COVID-19; conservative management; antibiotic therapy; laparoscopic appendicectomy; open surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; COVID-19; Appendicitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: PRN8996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As individual participant data contain private confidential data, this data will not be shared or made available publicly however the primary would be to answer or clarify any relevant queries.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No