Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-05-02 @ 1:39 AM
Study NCT ID:
NCT01953302
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2013-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D049291', 'term': 'Seroma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alen.pajtak@obv.hr', 'phone': '+38542393053', 'title': 'Alen Pajtak', 'organization': 'Varazdin General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Modified "Open Mesh Technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.\n\nmodified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified "Open Mesh Technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.\n\nmodified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.'}], 'classes': [{'title': 'Infection', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Seroma', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'No complications', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'four weeks after the surgery', 'description': 'we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Postoperative Hernia Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified "Open Mesh Technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.\n\nmodified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.'}], 'classes': [{'categories': [{'title': 'Reccurence with early complications', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Reccurence with infection', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No reccurence', 'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 36 months after the surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified "Open Mesh Technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.\n\nmodified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified "Open Mesh Technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.\n\nmodified "open mesh technique": We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Croatia', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-06', 'studyFirstSubmitDate': '2013-09-21', 'resultsFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2013-09-25', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-06', 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)', 'timeFrame': 'four weeks after the surgery', 'description': 'we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Postoperative Hernia Recurrence', 'timeFrame': 'up to 36 months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ventral hernia', 'infection', 'hematoma', 'seroma', 'recurrence', 'mesh technique'], 'conditions': ['Incisional Ventral Hernia', 'Recurrent Ventral Hernia']}, 'referencesModule': {'references': [{'pmid': '27209474', 'type': 'RESULT', 'citation': 'Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18.'}]}, 'descriptionModule': {'briefSummary': 'Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.', 'detailedDescription': 'We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 years or older\n* American Society of Anesthesiologists physical status I, II, III\n\nExclusion Criteria:\n\n* refusal of the patients to give informed consent'}, 'identificationModule': {'nctId': 'NCT01953302', 'briefTitle': 'Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Varazdin General Hospital'}, 'officialTitle': 'Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair', 'orgStudyIdInfo': {'id': '24011983'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'modified "open mesh technique"', 'description': 'We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.', 'interventionNames': ['Procedure: modified "open mesh technique"']}], 'interventions': [{'name': 'modified "open mesh technique"', 'type': 'PROCEDURE', 'otherNames': ['Proceed Surgical Mesh', 'VycrilTM,2-0 resorbing sutures'], 'description': 'We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.', 'armGroupLabels': ['modified "open mesh technique"']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HR-42000', 'city': 'Varaždin', 'country': 'Croatia', 'facility': 'Varazdin General Hospital', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}], 'overallOfficials': [{'name': 'Ranko Stare, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Varazdin General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Varazdin General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}