Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 5:18 PM
Study NCT ID:
NCT00775034
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-22', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': 'At time of discharge'}], 'secondaryOutcomes': [{'measure': 'Postoperative drainage volume', 'timeFrame': 'Day 0,1, 2, 3 ? and at day of removal'}, {'measure': 'Perioperative morbidity rate', 'timeFrame': 'At time of discharge'}, {'measure': 'Pain measured using VAS', 'timeFrame': 'Daily till discharge and after 3 weeks post-surgery'}, {'measure': 'Quality of life by SF-36 questionnaire', 'timeFrame': 'Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery'}, {'measure': 'Recurrence', 'timeFrame': 'At one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Incisional Hernia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Mesh repair for open incisional hernia repair with fibrin sealant or with drainage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients with a large incisional hernia \\>5cm diameter that needs elective repair with mesh augmentation\n\nExclusion Criteria:\n\n* no written informed consent\n* 'hostile' abdomen\n* emergency surgery (incarcerated hernia)\n* parastomal hernia\n* incisional hernia outside the midline\n* recurrent incisional hernia"}, 'identificationModule': {'nctId': 'NCT00775034', 'acronym': 'DREAM', 'briefTitle': 'Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair', 'orgStudyIdInfo': {'id': '2008/433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Study group (Tisseel®)', 'interventionNames': ['Drug: Tisseel®']}, {'type': 'OTHER', 'label': '2', 'description': 'Control group', 'interventionNames': ['Procedure: Drainage']}], 'interventions': [{'name': 'Tisseel®', 'type': 'DRUG', 'description': 'Mesh repair for open incisional hernia repair with fibrin sealant', 'armGroupLabels': ['1']}, {'name': 'Drainage', 'type': 'PROCEDURE', 'description': 'Mesh repair for open incisional hernia repair with drainage', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ gasthuisberg Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Frederik Berrevoet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}