Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 7:49 PM
Study NCT ID:
NCT02124356
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Performance Following Emergency High-risk Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'New Mobility Score (NMS)', 'timeFrame': 'At inclusion/baseline', 'description': 'NMS is a measure of pre-hospital functional level.'}], 'primaryOutcomes': [{'measure': 'Basic mobility evaluated by the Cumulated Ambulation Score (CAS)', 'timeFrame': 'Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).', 'description': 'Factors that limit independency in basic mobility will be evaluated on a daily basis.'}], 'secondaryOutcomes': [{'measure': 'Physical activity assessment with accelerometer (ActivePAL)', 'timeFrame': 'Daily on postoperative day 1 to 7.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).', 'description': 'VAS is a self-reported measure of pain intensity.'}, {'measure': 'Assessment of Motor and Process Skills (AMPS)', 'timeFrame': 'One time at postoperative day 4.', 'description': "AMPS measures a person's performance capacity for activities of daily living (ADL) and/or independent living."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Emergency High-risk Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).\n\nExclusion Criteria:\n\n* Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)'}, 'identificationModule': {'nctId': 'NCT02124356', 'briefTitle': 'Functional Performance Following Emergency High-risk Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Functional Performance Following Emergency High-risk Abdominal Surgery', 'orgStudyIdInfo': {'id': 'HH-AHA-FYS-01'}, 'secondaryIdInfos': [{'id': 'H-2-2014-FSP31', 'type': 'REGISTRY', 'domain': 'Regional Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency High-risk Abdominal Surgery', 'interventionNames': ['Other: Evaluation of functional performance']}], 'interventions': [{'name': 'Evaluation of functional performance', 'type': 'OTHER', 'armGroupLabels': ['Emergency High-risk Abdominal Surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seniorresearcher', 'investigatorFullName': 'Morten Tange Kristensen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}