Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00782704
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2008-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-09', 'studyFirstSubmitDate': '2008-10-29', 'studyFirstSubmitQcDate': '2008-10-29', 'lastUpdatePostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to develop and validate a morbidity index', 'timeFrame': 'preoeprativ and one day before discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['A self-administered questionnaire to collect data from patients, physicians and nurses about the severity of postoperative surgical complications.', 'Based on this questionnaire we will develop the morbidity index'], 'conditions': ['Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The aim is to develop and validate a morbidity index for postoperative complications in patients undergoing visceral surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients: all patients of the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich Nurses: Staff nurses of the University Hospital of Zurich Physicians: from different units of the University Hospital of Zurich (Visceral-, Thoracic, Cardiovascular Surgery, Anesthesiology, Intensiv Care Unit, Urology)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Capacity to act and no legal guardian\n* Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery\n* German language as daily language.\n\nExclusion Criteria:\n\n* Patients with cognitive difficulties and diseases, which may yield unreliable answers\n* Patients unable to read and write'}, 'identificationModule': {'nctId': 'NCT00782704', 'briefTitle': 'Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery', 'orgStudyIdInfo': {'id': 'StV 30-2008'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'questionnair for Patients'}, {'label': '2', 'description': 'questionnaire for Nurses'}, {'label': '3', 'description': 'questionnaire for Physicians'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Visceral and Transplantation Surgery of the University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Ksenija Slankamenac, med. pract', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Visceral and Transplantation Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Ksenija Slankamenac', 'investigatorAffiliation': 'University of Zurich'}}}}