Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615728
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2020-11-02
Brief Title:
MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
APPENDICITIS DURING THE COVID-19 PANDEMIC TO OPERATE OR NOT TO OPERATE THAT IS THE QUESTION COHORT STUDY FROM A TERTIARY CENTRE
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
observational
Brief 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
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 andor 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 ie 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 1700 until the following day at 0800 classified to have been performed out of hours
Operative details were recorded based on the operating surgeons 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
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 ie 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 1700 until the following day at 0800 classified to have been performed out of hours
Operative details were recorded based on the operating surgeons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None