Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:15 PM
Study NCT ID:
NCT07476560
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-16', 'size': 674747, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-05T09:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound', 'timeFrame': '7-13 days after operation', 'description': 'Definition: We will apply the standardized CDC (Centers for Disease Control and Prevention ) and VHWG (Ventral Hernia Working Group) definitions for SSO. Evaluation: Clinical examination. Additionally, an ultrasound examination will be performed.'}], 'secondaryOutcomes': [{'measure': 'Abdominal Hernia-Q Questionnaire', 'timeFrame': 'preoperative, postoperative day 10, day 90', 'description': 'Scale description: Disease-specific patient-reported outcome measure for abdominal hernia symptoms and quality of life.\n\nScore range: Each domain ranges from 1 to 4, where higher scores indicate better health status and fewer symptoms.'}, {'measure': 'EQ-5D-5L Index Score', 'timeFrame': 'preoperative, postoperative day 10, day 90', 'description': 'Scale description: Generic health-related quality-of-life instrument assessing five dimensions of health.\n\nScore range: The Index Score ranges from \\< 0 (worst health state, depending on country value set) to 1 (perfect health) and'}, {'measure': 'EQ-VAS (Visual Analogue Scale)', 'timeFrame': 'preoperative, postoperative day 10, day 90', 'description': 'Patients rate their overall health on a vertical scale from 0 to 100.\n\nInterpretation: Higher scores indicate better overall health-related quality of life.'}, {'measure': 'DURATION OF SURGERY', 'timeFrame': 'The time interval from the first incision to the last stitch is set', 'description': 'Operation time measured in minutes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Abdominal Wall Hernia', 'Umbilical Hernia Repair', 'Epigastric Hernia Repair']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias.\n\nThe main questions it aims to answer are:\n\nDoes mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh?\n\nComparison group:\n\nResearchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time.\n\nParticipants will:\n\nBe randomized to receive either planar mesh or mesh-suture during hernia repair surgery.\n\nUndergo standardized preoperative assessment, including baseline data and QoL scoring.\n\nAttend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ventral hernia (maximum size 3 × 3 cm) measured with Ultrasound or CT.\n* Participants must be eligible for surgical repair using either mesh-suture or planar mesh\n\nExclusion Criteria:\n\n* Age \\< 18 years.\n* Acute (emergent) operation.\n* Pregnancy.\n* Women with plans for future pregnancies.\n* Withdrawal of informed consent during admission.'}, 'identificationModule': {'nctId': 'NCT07476560', 'acronym': 'MeMa', 'briefTitle': 'Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Regionshospital Nordjylland'}, 'officialTitle': 'Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study', 'orgStudyIdInfo': {'id': 'VMK-id:2502170'}, 'secondaryIdInfos': [{'id': 'VMK-id:2502170', 'type': 'OTHER', 'domain': 'Danish Research Ethics Committees'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesh suture', 'interventionNames': ['Device: mesh suture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'planar mesh', 'interventionNames': ['Device: planar mesh']}], 'interventions': [{'name': 'mesh suture', 'type': 'DEVICE', 'description': 'mesh suture', 'armGroupLabels': ['mesh suture']}, {'name': 'planar mesh', 'type': 'DEVICE', 'description': 'planar mesh', 'armGroupLabels': ['planar mesh']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hjørring', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Vitaly A Gameza', 'role': 'CONTACT', 'email': 'vitgam@rn.dk', 'phone': '045 97640520'}], 'facility': 'Regionshospital Nordjylland', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}], 'centralContacts': [{'name': 'Vitaly A Gameza', 'role': 'CONTACT', 'email': 'vitgam@rn.dk', 'phone': '045 97640520'}, {'name': 'Katrine Holte', 'role': 'CONTACT', 'email': 'k.holte@rn.dk', 'phone': '045 97640520'}], 'overallOfficials': [{'name': 'Nils Brandenburger', 'role': 'STUDY_CHAIR', 'affiliation': 'Regionhospital Nordjylland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethics commettee requirements'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospital Nordjylland', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}