Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 9:34 AM
Study NCT ID:
NCT05375058
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2022-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complicated Appendicitis During the COVID-19 Pandemic in Jordan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': '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': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of postoperative complications', 'timeFrame': 'Up to 2 years', 'description': 'To determine if there were any complications, this was detected by reviewing the histopathology report'}], 'secondaryOutcomes': [{'measure': 'Length of in-hospital stay', 'timeFrame': 'Up to 2 years', 'description': 'How many days did the patient spend in the hospital until discharged.'}, {'measure': 'Imaging method used for diagnosis (CT or US)', 'timeFrame': 'Up to 2 years', 'description': 'How was appendicitis diagnosed, either by using Computed Tomography (CT) Scan or Ultrasound.'}, {'measure': 'Type of operation (open or laparoscopic)', 'timeFrame': 'Up to 2 years', 'description': 'We reported what type of operation the patient underwent to treat appendicitis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Complicated Appendicitis']}, 'descriptionModule': {'briefSummary': 'Comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.', 'detailedDescription': 'The investigators have retrospectively investigated data on acute appendicitis cases. Two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the COVID-19 pandemic in Jordan University Hospital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient that has a medical record for appendicitis and underwent appendectomy at University of Jordan hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient that presented with appendicitis and underwent an appendectomy at the university of Jordan hospital during the specified time periods (March 2019-December 2020)\n\nExclusion Criteria:\n\n* Incomplete data record.'}, 'identificationModule': {'nctId': 'NCT05375058', 'briefTitle': 'Complicated Appendicitis During the COVID-19 Pandemic in Jordan', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University Hospital'}, 'officialTitle': 'Impact of the COVID-19 Pandemic on the Incidence of Complicated Appendicitis in a Tertiary Medical Center, Amman, Jordan: A Retrospective Cohort', 'orgStudyIdInfo': {'id': '28/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pandemic group (2020)', 'description': 'includes patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of March to the 6th of June 2020', 'interventionNames': ['Other: Observational Study']}, {'label': 'pre-pandemic group (2019)', 'description': 'which represents the same period in the previous year'}], 'interventions': [{'name': 'Observational Study', 'type': 'OTHER', 'description': 'Observational Study; the study did not involve any interventions', 'armGroupLabels': ['pandemic group (2020)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11942', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan University Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'overallOfficials': [{'name': 'Marzouq Amarin, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General Surgery, the University of Jordan, Amman, 11942, Jordan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Abdallah Raed Al-Qawasmeh', 'investigatorAffiliation': 'Jordan University Hospital'}}}}