Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
Study NCT ID:
NCT04615728
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': 'Death secondary to acute appendicitis'}, {'measure': 'Failure of primary proposed treatment', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': 'failure of conservative management and need to undergo surgery'}], 'secondaryOutcomes': [{'measure': 'length of stay', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': 'length of stay in hospital from admission date till discharge date or death'}, {'measure': 'Re-attendance', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': "Re-attendance to hospital after patient's discharge whether planned or unplanned"}, {'measure': 'Imaging', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': 'imaging modality obtained and findings to confirm the diagnosis of acute appendicitis'}, {'measure': 'Intra-operative findings during surgery', 'timeFrame': "within 90 days of a patient's initial presentation", 'description': 'Intra-operative findings of pus or free fluid during appendicectomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute appendicitis; COVID-19; conservative management; antibiotic therapy; laparoscopic appendicectomy; open surgery'], 'conditions': ['Acute Appendicitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nData 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.\n\nStudy 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.\n\nOperative 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 16 years old and above\n* Confirmed diagnosis of acute appendicitis\n\nExclusion Criteria:\n\n* Patients aged less than 16 years old'}, 'identificationModule': {'nctId': 'NCT04615728', 'acronym': 'observational', 'briefTitle': 'MANAGEMENT OF APPENDICITIS DURING THE COVID-19 PANDEMIC', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'APPENDICITIS DURING THE COVID-19 PANDEMIC: TO OPERATE OR NOT TO OPERATE, THAT IS THE QUESTION: COHORT STUDY FROM A TERTIARY CENTRE', 'orgStudyIdInfo': {'id': 'PRN8996'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-COVID cohort', 'description': 'Patients recruited from 1st November 2019 to 9th March 2020', 'interventionNames': ['Procedure: laparoscopic or open appendicectomy']}, {'label': 'COVID cohort', 'description': 'Patients recruited from 10th March 2020 to 5th July 2020', 'interventionNames': ['Procedure: laparoscopic or open appendicectomy']}], 'interventions': [{'name': 'laparoscopic or open appendicectomy', 'type': 'PROCEDURE', 'otherNames': ['conservative antibiotic therapy'], 'description': 'Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection', 'armGroupLabels': ['COVID cohort', 'pre-COVID cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': "Addenbrooke's University Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "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", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Mr Ramez Antakia', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}