Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 4:00 PM
Study NCT ID:
NCT04358159
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2020-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT Ventralex vs Onlay Mesh in Incisional Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and staff responsible for the postoperative care of the patient are masked to the acollcation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial of Vantralex versus Progrip for repair of midline incisional hernias'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'One year', 'description': 'Rate of hernia recurrences diagnosed at clinical and/or radiologic examination'}], 'secondaryOutcomes': [{'measure': 'Rate ofntra- and postoperative complications', 'timeFrame': '30 days', 'description': 'Rate of complications occurring during or after the repair'}, {'measure': 'Rate of seroma', 'timeFrame': 'one year', 'description': 'Postoperative seroma'}, {'measure': 'Persisting postoperative pain', 'timeFrame': 'One year', 'description': 'Pain interfering with daily activities as rated with Ventral Hernia Pain Questionnaire'}, {'measure': 'Sick leave', 'timeFrame': '30 days', 'description': 'Mean number of postoperative days sick leave'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incisional Hernia of Midline of Abdomen']}, 'descriptionModule': {'briefSummary': 'A radomised controlled trial comparing Ventralex patch and Progrip mesh in surgery for midline incisional hernias', 'detailedDescription': 'Incisional hernias in the midline is among the most common conditions requiring surgery. There are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities.\n\nRepair with mesh-reinforcement is considered standard for the treatment of incisional hernias. Onlay and sublay mesh placements are the most commonly used methods. There are many different types of mesh available to use. Despite the widely use of composite ventral-patch Ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. Some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. The Ventralex mesh is usually placed on the peritoneum as a Intra peritoneum onlay mesh (IPOM). In this study intend to compare pre peritoneal Ventralex® mesh in sublay position with ProGrip self-fixating onlay mesh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hernia defect 1-4 cm\n* Incisional hernia or recurrent hernia after previous primary hernia repair\n* BMI \\<35\n* Age 18-100 years\n\nExclusion Criteria:\n\n* Defect size\\>4 cm\n* Ongoing pregnancy\n* BMI\\>35\n* Primary hernia'}, 'identificationModule': {'nctId': 'NCT04358159', 'acronym': 'VPatchIncRCT', 'briefTitle': 'RCT Ventralex vs Onlay Mesh in Incisional Hernias', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Randomised Controlled Trial of Ventralex Versus Onlay Mesh Repair for Midline Incisional Hernias', 'orgStudyIdInfo': {'id': 'VPatchIncRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventralex', 'description': 'Repair with Ventralex patch in sublay position', 'interventionNames': ['Device: Ventralex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Progrip', 'description': 'Repair with Progrip in Onlay position', 'interventionNames': ['Device: Progrip']}], 'interventions': [{'name': 'Ventralex', 'type': 'DEVICE', 'description': 'Repair of the hernia by a Ventralex patch in sublay position', 'armGroupLabels': ['Ventralex']}, {'name': 'Progrip', 'type': 'DEVICE', 'description': 'Repair of the hernia by a Progrip mesh in onlay position', 'armGroupLabels': ['Progrip']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karlskoga', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Asmatullah Katawazai, MD', 'role': 'CONTACT'}], 'facility': 'Karlskoga Hospital', 'geoPoint': {'lat': 59.32667, 'lon': 14.52386}}, {'city': 'Karlskoga', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Asmatullah Katawazai, MD', 'role': 'CONTACT', 'email': 'asmatullah.katawazai@regionorebrolan.se'}, {'name': 'Gabriel Sandblom, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.sandblom@ki.se'}], 'facility': 'Karlskoga Hospital', 'geoPoint': {'lat': 59.32667, 'lon': 14.52386}}], 'centralContacts': [{'name': 'Gabriel Sandblom, MD, PhD', 'role': 'CONTACT', 'email': 'gabriel.sandblom@ki.se', 'phone': '+4686162362'}, {'name': 'Asmatullah Katawazai, MD', 'role': 'CONTACT', 'email': 'asmatullah.katawazai@regionorebrolan.se', 'phone': '+46586660 00'}], 'overallOfficials': [{'name': 'Gabriel Sandblom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gabriel Sandblom', 'investigatorAffiliation': 'Karolinska Institutet'}}}}