Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-29 @ 5:19 AM
Study NCT ID:
NCT02321059
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2014-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal wall strength measured by the Goodstrength system', 'timeFrame': 'One week', 'description': 'Change in abdominal wall strength from baseline to follow-up.'}], 'secondaryOutcomes': [{'measure': 'Physical activity the last week, assessed by the International Physical Activity Questionnaire', 'timeFrame': 'Once, at baseline examination'}, {'measure': 'Self-assessed abdominal wall strength, as measured on a visual analogue scale', 'timeFrame': 'Once, at baseline examination'}, {'measure': 'Trunk extensor strength measured by the Goodstrength system', 'timeFrame': 'One week', 'description': 'Change in trunk extensor strength from baseline to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['incisional hernia', 'hernia', 'abdominal wall strength', 'validation', 'physical activity'], 'conditions': ['Incisional Hernia']}, 'descriptionModule': {'briefSummary': 'Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists score 1-3\n* Age equal to or above 18\n* Ventral incisional hernia OR intact abdominal wall\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe heart disease (New York Heart Association class III-IV)\n* Severe pulmonary disease\n* Severe musculoskeletal disease\n* Systemic treatment with glucocorticoid'}, 'identificationModule': {'nctId': 'NCT02321059', 'acronym': 'VAGSI', 'briefTitle': 'Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia', 'orgStudyIdInfo': {'id': 'H-1-2014-008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No incisional hernia group', 'description': 'Healthy volunteers with an intact abdominal wall.', 'interventionNames': ['Device: Measurement of abdominal wall strength']}, {'label': 'Incisional hernia group', 'description': 'Patients with a ventral incisional hernia.', 'interventionNames': ['Device: Measurement of abdominal wall strength']}], 'interventions': [{'name': 'Measurement of abdominal wall strength', 'type': 'DEVICE', 'description': 'Test-retest examination of the reliability of the Goodstrength trunk dynamometer', 'armGroupLabels': ['Incisional hernia group', 'No incisional hernia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital'}], 'overallOfficials': [{'name': 'Kristian K Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kristian Kiim Jensen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}