Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-04 @ 5:21 PM
Study NCT ID:
NCT00647569
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2008-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2013-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incisional hernia formation determined by CT scan 1 year postoperative', 'timeFrame': '1 year postoperative'}], 'secondaryOutcomes': [{'measure': 'postoperative morbidity', 'timeFrame': '30 days postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vertical rectus abdominis musculocutaneus flap', 'mesh repair', 'salvage surgery'], 'conditions': ['Incisional Hernia', 'Pelvic Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the present project is to investigate whether use of biological mesh at the donor site of the rotation flap in closure of the abdominal wall reduce the frequency of incisional hernia formation compared to the usual abdominal wall closure after abdominal rotation flap operation in surgery for advanced pelvic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients operated with a vertical rectus abdominis musculocutaneus flap after abdominoperineal resection for advanced pelvic cancer.\n\nExclusion Criteria:\n\n* Pre or perioperative knowledge of disseminated malignancy\n* Unable to follow the control program\n* Known allergy to pig\n* Compromised immune defense\n* Artificial heart valve or recent (\\< 3 months) implanted foreign body\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT00647569', 'acronym': 'VRAM', 'briefTitle': 'Trial of Collagen Mesh for Prevention of Ventral Hernia After Surgery for Advanced Pelvic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Randomized Controlled Trial of Collagen Mesh for Prevention of Ventral Hernia in Patients With Vertical Rectus Abdominis Musculocutaneus Flap for Advanced Pelvic Malignancy', 'orgStudyIdInfo': {'id': 'VRAM M-20070240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'No previous major abdominal surgery', 'interventionNames': ['Procedure: Mesh repair', 'Procedure: Conventional facial closure']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Previous major abdominal surgery', 'interventionNames': ['Procedure: Mesh repair', 'Procedure: Conventional facial closure']}], 'interventions': [{'name': 'Mesh repair', 'type': 'PROCEDURE', 'otherNames': ['Surgisis Gold Hernia repair graft'], 'description': 'A Surgisis Gold Hernia repair graft (Cook Biotech Incorporated, West Lafayette, IN, U.S.A) is placed at the donor site of the rectus abdominis muscles used for the rotation flap before the abdominal fascia is sutured with continuous running suture.', 'armGroupLabels': ['A', 'B']}, {'name': 'Conventional facial closure', 'type': 'PROCEDURE', 'description': 'The abdominal facia is closed with with continuous running suture', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Surgical Research Unit, Department of Surgery P, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Peter Christensen, M.D., Ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery P, Aarhus University Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cook Biotech Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}