Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-17 @ 2:55 PM
Study NCT ID:
NCT04196166
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2019-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Preoperative Evaluation in Surgical Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative blood tests compliance rate with institutional guidelines', 'timeFrame': '2014-2019', 'description': 'compliance rate (%) with institutional and international guidelines measured by a questionnaire including whether participant was advised preoperative lab tests in compliance with the institutional guidelines or not.'}], 'secondaryOutcomes': [{'measure': 'Cost difference in local currency', 'timeFrame': '2014-2019', 'description': 'of compliant group Vs non compliant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative evaluation', 'orthopedic surgery'], 'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'The "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/ major surgery are not justified. In this study of 670 healthy orthopedic patients with 7610 preoperative tests, investigators found that surgical plan was influenced in \\<1% of patients. Surgeons should be sensitized to reconsider this practice particularly with limited resources.', 'detailedDescription': 'Background: Routine preoperative tests in healthy patients not only cause extra anxiety, but may delay treatment without influencing surgical plan. This has worse impact in resource-constrained settings where fee for service rather than health insurance is the usual norm. Investigators aim to determine if "routine" pre-operative tests are justified in healthy orthopedic patients.\n\nMethods: Investigators conducted a non-commercialized, non-funded matched case control study in tertiary care university hospital and a level-1 trauma centre for healthy patients (ASA-1\\&2) admitted from January 2014-December 2016 for elective orthopedic intermediate and major procedures. Cases (patient who had a change in his/her surgical plan after admission) and controls were selected independently of the exposure of interest then matched randomly to cases on age, gender and procedure type. Primary exposure was the routine preoperative lab tests, as defined by the American Society of Anesthesiologist, which included 13 blood tests. Analysis was done using Principle Component Analysis and Conditional logistic regression at univariate and multivariable levels reporting matched adjusted Odds Ratios. The data will bereported in line with STROBE criteria.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients irrespective of age and gender who were classified as ASA-1 and ASA-2 by the anesthesia team and who underwent minor, intermediate and major primary elective orthopedic procedures', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants irrespective of age and gender.\n* ASA-1 and ASA-2 status.\n* Primary elective orthopedic procedures.\n* Blood lab tests done at the institution only.\n\nExclusion Criteria:\n\n* Ambulatory care procedures\n* Revision surgery.\n* Participants admitted to other services, high care or intensive care units.'}, 'identificationModule': {'nctId': 'NCT04196166', 'briefTitle': 'Routine Preoperative Evaluation in Surgical Patient', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Does More Testing in Routine Preoperative Evaluation Benefit the Surgical Patient? Matched Case Control Study From a Resource-constrained Setting', 'orgStudyIdInfo': {'id': '4226-Sur-ERC-16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'nested from on going retrospective cohort study. Participants who had change in their surgical plan after hospitalization.', 'interventionNames': ['Other: preoperative blood tests']}, {'label': 'Controls', 'description': "nested from on going retrospective cohort study. Participants who didn't have change in their surgical plan after hospitalization.", 'interventionNames': ['Other: preoperative blood tests']}], 'interventions': [{'name': 'preoperative blood tests', 'type': 'OTHER', 'armGroupLabels': ['Cases', 'Controls']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not allowed by organisation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Obada Hasan, FCPS, MRCS, MSc (Epidemiology&Biostatistics)', 'investigatorAffiliation': 'Aga Khan University'}}}}