Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-26 @ 4:44 PM
Study NCT ID:
NCT01003067
Status:
UNKNOWN
Last Update Posted:
2019-08-15
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraperitoneal Mesh-Implementation After Laparotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christoph.maurer@hin.ch', 'phone': '+41 31 335 33 33', 'title': 'Prof. Christoph A. Maurer', 'organization': 'Hirslanden Bern'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Mesh', 'description': 'conventional abdominal closure with a suture', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 0, 'seriousNumAtRisk': 136, 'deathsNumAffected': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mesh Implementation', 'description': 'Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 2, 'seriousNumAtRisk': 131, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bowel Fistulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Mesh', 'description': 'conventional abdominal closure with a suture'}, {'id': 'OG001', 'title': 'Mesh Implementation', 'description': 'Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.', 'timeFrame': '5 Years', 'description': 'Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2020-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Mesh', 'description': 'conventional abdominal closure with a suture'}, {'id': 'FG001', 'title': 'Mesh Implementation', 'description': 'Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Mesh', 'description': 'The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).'}, {'id': 'BG001', 'title': 'Mesh Implementation', 'description': 'Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '2', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2009-10-27', 'resultsFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-06', 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy', 'timeFrame': '2 years', 'description': 'Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.', 'timeFrame': '5 Years', 'description': 'Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '30824961', 'type': 'DERIVED', 'citation': 'Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.'}, {'pmid': '29159603', 'type': 'DERIVED', 'citation': 'Brosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Median Laparotomy\n\nExclusion Criteria:\n\n* Bowel perforation\n* Pregnancy\n* Palliative surgery\n* Drug abuse\n* Age under 18\n* Mental disability\n* Allergy to mesh components'}, 'identificationModule': {'nctId': 'NCT01003067', 'briefTitle': 'Intraperitoneal Mesh-Implementation After Laparotomy', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '364/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Mesh'}, {'type': 'EXPERIMENTAL', 'label': 'Mesh Implementation', 'interventionNames': ['Device: Mesh implementation']}], 'interventions': [{'name': 'Mesh implementation', 'type': 'DEVICE', 'description': 'Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.', 'armGroupLabels': ['Mesh Implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonsspital Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Christoph A. Maurer', 'investigatorFullName': 'Christoph A. Maurer, MD', 'investigatorAffiliation': 'Kantonsspital Liestal'}}}}