MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
NCT ID: NCT04615728
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2019-11-01
2020-10-06
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pre-COVID cohort
Patients recruited from 1st November 2019 to 9th March 2020
laparoscopic or open appendicectomy
Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection
COVID cohort
Patients recruited from 10th March 2020 to 5th July 2020
laparoscopic or open appendicectomy
Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection
Interventions
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laparoscopic or open appendicectomy
Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of acute appendicitis
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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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
UNKNOWN
Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Mr Ramez Antakia
Mr
Locations
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Addenbrooke's University Hospital
Cambridge, Cambridgeshire, United Kingdom
Countries
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Other Identifiers
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PRN8996
Identifier Type: -
Identifier Source: org_study_id