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CompletedNCT04615728observationalUpdated Nov 4, 2020

MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC

An observational study in Acute Appendicitis, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Acute Appendicitis

Keywords

  • acute appendicitis; COVID-19; conservative management; antibiotic therapy; laparoscopic appendicectomy; open surgery
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 207 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients aged less than 16 years old
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (actual)
Patient registry
No

Groups and cohorts

  • pre-COVID cohort

    Patients recruited from 1st November 2019 to 9th March 2020

    Procedure: laparoscopic or open appendicectomy

  • COVID cohort

    Patients recruited from 10th March 2020 to 5th July 2020

    Procedure: laparoscopic or open appendicectomy

Interventions

  • Procedurelaparoscopic or open appendicectomy

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

    Also known as: conservative antibiotic therapy

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What researchers measure

Primary outcomes

  1. Mortality

    Death secondary to acute appendicitis

    Time frame: within 90 days of a patient's initial presentation

  2. Failure of primary proposed treatment

    failure of conservative management and need to undergo surgery

    Time frame: within 90 days of a patient's initial presentation

Secondary outcomes

  1. length of stay

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

    Time frame: within 90 days of a patient's initial presentation

  2. Re-attendance

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

    Time frame: within 90 days of a patient's initial presentation

  3. Imaging

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

    Time frame: within 90 days of a patient's initial presentation

  4. Intra-operative findings during surgery

    Intra-operative findings of pus or free fluid during appendicectomy

    Time frame: within 90 days of a patient's initial presentation

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Study locations

1 site
  • Addenbrooke's University Hospital
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04615728
Lead 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
Responsible party
Mr Ramez Antakia (Mr, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Nov 4, 2020
Start date
Nov 1, 2019
Primary completion
Jul 5, 2020
Completion
Oct 6, 2020
Last update
Nov 4, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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