[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615222":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":30,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"Swissmed Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"3DMax MID TAPP\u002FTEP",null,"Adult patients undergoing elective laparoendoscopic inguinal hernia repair (TAPP or TEP) with implantation of the 3DMax MID Anatomical Mesh (BD, USA) as part of routine clinical practice. No randomization or control group is used; all enrolled participants receive the same type of mesh according to the treating surgeon's standard technique.",[13],"Device: 3DMax MID Anatomical Mesh",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","3DMax MID Anatomical Mesh","Implantation of a pre-shaped, medium-weight, macroporous polypropylene anatomical mesh (3DMax MID Anatomical Mesh, BD, USA) during elective laparoendoscopic inguinal hernia repair (TAPP or TEP) as part of routine clinical practice. No additional experimental procedures beyond standard surgical care are planned.",[9],[21],"3DMax MID",[23,27],{"name":24,"affiliation":25,"role":26},"Maciej Śmietański, Prof.","LUX MED Hospital in Gdańsk","STUDY_CHAIR",{"name":28,"affiliation":25,"role":29},"Mateusz Zamkowski, MD, PhD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","22 543 33 60","zamek@gumed.edu.pl",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100615222","safety-and-efficacy-of-the-3dmax-mid-anatomical-mesh-bd-usa-in-laparoscopic-endoscopic-inguinal-hernia-repair---multicenter-prospective-observational-study-100615222",false,"NCT07289802","Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair - Multicenter, Prospective Observational Study","Safety and Efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in Laparoendoscopic Inguinal Hernia Repair: A Multicenter Prospective Observational Cohort Study","3DMS","Inclusion Criteria:\n\n* Age 18 years or older\n* Primary unilateral or bilateral inguinal hernia\n* Scheduled for elective laparoendoscopic inguinal hernia repair (TAPP or TEP)\n* Considered suitable for general anesthesia and laparoendoscopic approach by the treating surgeon\n* 3DMax MID Anatomical Mesh planned for use as part of routine clinical care\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years\n* Emergency surgery (e.g. incarcerated or strangulated hernia requiring urgent intervention)\n* Contaminated or potentially contaminated surgical field\n* Recurrent inguinal hernia in the same groin (previous repair with mesh or suture)\n* Concomitant procedures or clinical situations in which the surgeon decides that a different mesh concept or technique is required\n* Inability or unwillingness to comply with follow-up schedule (e.g. lack of telephone contact, severe cognitive impairment)","ALL","18 Years",{"count":48,"type":49},300,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice.\n\nThe primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications.\n\nAll participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.",[53],"Hernia, Inguinal",[55,56,57,58],"Hernia","Mesh","Inguinal Hernia","Recurrence","NOT_YET_RECRUITING","2025-12-04",{"date":62,"type":63},"2025-12-17","ACTUAL",{"date":65,"type":49},"2026-01-01",{"date":67,"type":49},"2027-04-01",{"name":5,"class":6}]