MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC

Acute Appendicitis Clinical Trial

— observational  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615728
• Other study ID #: PRN8996
• Status: Completed
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 6, 2020
• Est. primary completion date: July 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 16 years old and above

• Confirmed diagnosis of acute appendicitis

Exclusion Criteria:

• Patients aged less than 16 years old

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Procedure:
• laparoscopic or open appendicectomy
Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's University Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death secondary to acute appendicitis	within 90 days of a patient's initial presentation
Primary	Failure of primary proposed treatment	failure of conservative management and need to undergo surgery	within 90 days of a patient's initial presentation
Secondary	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
Secondary	Re-attendance	Re-attendance to hospital after patient's discharge whether planned or unplanned	within 90 days of a patient's initial presentation
Secondary	Imaging	imaging modality obtained and findings to confirm the diagnosis of acute appendicitis	within 90 days of a patient's initial presentation
Secondary	Intra-operative findings during surgery	Intra-operative findings of pus or free fluid during appendicectomy	within 90 days of a patient's initial presentation