Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT02770703
Status:
TERMINATED
Last Update Posted:
2022-03-17
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'USB is responsible party on behalf of the principal investigator (PI). As PI cannot be tracked (lost to follow-up), the USB as "sponsor" set "overall recruitment status" unless the PI can be identified or tracked.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Mesh Position per MRI', 'timeFrame': '90 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Mesh Deformation per MRI', 'timeFrame': '90 days postoperatively'}, {'measure': 'Groin pain using visual analogue scale', 'timeFrame': '0, 1, 90, 365 days postoperatively'}, {'measure': 'Recurrence of hernia', 'timeFrame': '0, 1, 90, 365 days postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Unilateral Simple Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.\n\nTwo of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control.\n\nUntil now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.\n\nIn this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients with a primary symptomatic unilateral inguinal hernia.\n* Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or open techniques (e.g. Lichtenstein) as judged by the treating surgeon\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous inguinal hernia repair\n* Bilateral inguinal hernia\n* Femoral hernia repair\n* Repair in local anesthetics,\n* Previous abdominal surgery\n* Children\n* Emergency surgery, e.g. incarcerated hernias\n* Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea implants, claustrophobia)\n* Contraindications to usage of mesh e.g. known hypersensitivity or allergy\n* Women who are pregnant or breast feeding\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia\n* American Society of Anesthesiologists (ASA) classification higher or equal to 3'}, 'identificationModule': {'nctId': 'NCT02770703', 'briefTitle': 'Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh', 'orgStudyIdInfo': {'id': 'BASEC 2016-00085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open inguinal hernia repair (Lichtenstein)', 'description': 'Open inguinal hernia repair using a DynaMesh visible mesh', 'interventionNames': ['Device: DynaMesh visible mesh']}, {'type': 'EXPERIMENTAL', 'label': 'Total extraperitoneal inguinal hernia repair (TEP)', 'description': 'Total extraperitoneal inguinal hernia repair using a DynaMesh visible mesh', 'interventionNames': ['Device: DynaMesh visible mesh']}, {'type': 'EXPERIMENTAL', 'label': 'Trans abdominal preperitoneal hernia repair (TAPP)', 'description': 'Trans abdominal preperitoneal hernia repair using a DynaMesh visible mesh', 'interventionNames': ['Device: DynaMesh visible mesh']}], 'interventions': [{'name': 'DynaMesh visible mesh', 'type': 'DEVICE', 'description': 'Implantation of a MRI visible mesh', 'armGroupLabels': ['Open inguinal hernia repair (Lichtenstein)', 'Total extraperitoneal inguinal hernia repair (TEP)', 'Trans abdominal preperitoneal hernia repair (TAPP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital of Basel, Department of Surgery', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Robert Mechera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Basel, Department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}