Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-20 @ 3:44 AM
Study NCT ID:
NCT02089958
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2014-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardization of Laparoscopic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2014-03-15', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Wound infection', 'timeFrame': '12 mts postoperatively', 'description': 'Measured along SSI-classification'}], 'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'until 12 mths postoperatively'}], 'secondaryOutcomes': [{'measure': 'Pain, Quality of Life', 'timeFrame': 'until 12 mths postoperatively', 'description': 'Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lapraoscopy, incisional hernia repair, mesh'], 'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '29736474', 'type': 'DERIVED', 'citation': 'Hellinger A, Wotzlaw F, Fackeldey V, Pistorius G, Zdichavsky M, Junemann R, Buia A. Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial). Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.', 'detailedDescription': 'Data are scheduled for publication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pts. with incisional hernia following prior abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary incisional hernia\n* Hernia size EHS W 1-2\n* Hernia location EHS M 1-5, L 1-3\n* Clinical symptoms or progressive growth of hernia\n\nExclusion Criteria:\n\n* Recurrent incisional hernia\n* Ventral hernie\n* Hernia size \\> EHS W 2\n* Hernia location EHS L 4, ASA \\>3\n* Prospective mesh overlap \\< 5 cm\n* Malignant disease'}, 'identificationModule': {'nctId': 'NCT02089958', 'acronym': 'LIPOM', 'briefTitle': 'Standardization of Laparoscopic Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Fulda'}, 'officialTitle': 'Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study', 'orgStudyIdInfo': {'id': 'AE 003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic incisional hernia repair', 'description': 'Incisional hernia, LIPOM', 'interventionNames': ['Procedure: Laparoscopic incisional hernia repair']}], 'interventions': [{'name': 'Laparoscopic incisional hernia repair', 'type': 'PROCEDURE', 'otherNames': ['LIPOM'], 'description': 'Standardized laparoscopic incisional hernia repair with mesh', 'armGroupLabels': ['Laparoscopic incisional hernia repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36039', 'city': 'Fulda', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum Fulda', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}], 'overallOfficials': [{'name': 'Achim Hellinger, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Fulda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Fulda', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv. Doz. Dr. med.', 'investigatorFullName': 'Achim Hellinger', 'investigatorAffiliation': 'Klinikum Fulda'}}}}