Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05516420
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2022-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predicting Abdominal Reoperation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-30', 'releaseDate': '2024-12-27'}], 'estimatedResultsFirstSubmitDate': '2024-12-27'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-07', 'size': 469344, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-17T05:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with an abdominal reoperation in the study cohort', 'timeFrame': 'within 5 years postoperatively', 'description': 'Number of patients undergoing a reoperation after abdominal surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Abdominal Adhesion']}, 'descriptionModule': {'briefSummary': 'Nationwide retrospective study, to predict the risk of abdominal reoperation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.\n\nExclusion Criteria:\n\n* Positive history for abdominal surgery'}, 'identificationModule': {'nctId': 'NCT05516420', 'briefTitle': 'Predicting Abdominal Reoperation', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Predicting Long-term Risk of Reoperations Following Abdominal and Pelvic Surgery: a Nationwide Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'SCARreop'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with first abdominal surgery in Scotland between 2009 and 2011', 'description': 'Patients with first abdominal surgery in Scotland between 2009 and 2011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available from the Scottish National Health Service (NHS). Restrictions apply to the availability of these data, which were used under license for this study. Data derived from the analysis are available from the authors with the permission of the Scottish NHS.\n\nThe used repository was the Safe Haven (https://shs.epcc.ed.ac.uk/2fa/scotnsh.html) from the NHS.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Research Scotland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard ten Broek', 'investigatorAffiliation': 'Radboud University Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-27', 'type': 'RELEASE'}, {'date': '2025-01-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Richard ten Broek, Principal Investigator, Radboud University Medical Center'}}}}