Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
Study NCT ID:
NCT04519268
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2020-08-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003128', 'term': 'Coma'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Adherence to NICE-UK Guidelines', 'timeFrame': 'one week', 'description': 'The degree of adherence of the current practices at Kasr Alaini hospital preoperative testing to the NICE-UK guidelines, determined as a "percentage".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-anesthetic tests', 'NICE-UK guidlines', 'Kasr Alaini hospital'], 'conditions': ['Anesthesia', 'Surgery', 'Exanimation']}, 'descriptionModule': {'briefSummary': "Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial.\n\nThe National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations.\n\nThe aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay \\& its effect to predict postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients that will be scheduled for an elective surgical operation at Kasr Alaini hospital during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients scheduled for elective surgical operations.\n\nExclusion Criteria:\n\n* Patients operated upon an emergency basis.\n* Pregnant females.\n* Patients scheduled for cardio-thoracic and neurosurgical procedures.'}, 'identificationModule': {'nctId': 'NCT04519268', 'briefTitle': 'Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-UK Guidelines, and Its Effect on Decision Making & Patient Outcome: Prospective Observational Study', 'orgStudyIdInfo': {'id': 'ADPAT-KAH-NICEUKG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elective Surgical Adult Patients', 'description': 'Adult patients scheduled for an elective general surgical operation.', 'interventionNames': ['Diagnostic Test: Adult patients scheduled for an elective general surgical operation.']}], 'interventions': [{'name': 'Adult patients scheduled for an elective general surgical operation.', 'type': 'DIAGNOSTIC_TEST', 'description': "The anesthesiologist, who is in charge of preoperative assessment at each hospital unit, will assess patients who are scheduled for elective surgery; and will inform senior anesthesiologists (with a minimum 3 years of experience) \\& consultant anesthesiologists, about the patients' data.\n\nPatients data with all requested preoperative investigations \\& required preparations, peri-operative course and post-operative outcome will be collected.", 'armGroupLabels': ['Elective Surgical Adult Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Beshoy A Naguib, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}, {'name': 'Nazmy S Michael, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}, {'name': 'Manar M Elkholy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nazmy Edward Seif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Nazmy Edward Seif', 'investigatorAffiliation': 'Cairo University'}}}}