Addenbrooke's University Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
NCT Number: NCT04615728
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.
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Notify Me16 year and older
All sexes
Observational
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection
Other names: conservative antibiotic therapy
Time frame: within 90 days of a patient's initial presentation
Death secondary to acute appendicitis
Time frame: within 90 days of a patient's initial presentation
failure of conservative management and need to undergo surgery
Time frame: within 90 days of a patient's initial presentation
length of stay in hospital from admission date till discharge date or death
Time frame: within 90 days of a patient's initial presentation
Re-attendance to hospital after patient's discharge whether planned or unplanned
Time frame: within 90 days of a patient's initial presentation
imaging modality obtained and findings to confirm the diagnosis of acute appendicitis
Time frame: within 90 days of a patient's initial presentation
Intra-operative findings of pus or free fluid during appendicectomy
Cambridge University Hospitals NHS Foundation Trust
Other
APPENDICITIS DURING THE COVID-19 PANDEMIC: TO OPERATE OR NOT TO OPERATE, THAT IS THE QUESTION: COHORT STUDY FROM A TERTIARY CENTRE
Acronym: observational
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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