[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657582":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":44,"studyPopulation":34,"armGroups":45,"interventions":58,"overallOfficials":68,"centralContacts":73,"locations":81,"responsibleParty":100,"collaborators":34,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":34,"enrollmentInfo":113,"targetDuration":34,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":83,"whyStopped":34,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Hospital Zonal General De Agudos Mario V Larrain","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"Recurrence rate of incisional hernia","Proportion of participants with hernia recurrence, assessed by clinical physical examination and confirmed by abdominal wall ultrasound when clinically indicated. All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant.","18-24 months (final follow-up visit)",{"measure":14,"description":15,"timeFrame":16},"Rate of Major Intraoperative and Postoperative Complications","Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity.","Throughout study participation (up to 24 months)",[18,22,26,30],{"measure":19,"description":20,"timeFrame":21},"Operative time and fascial closure time","Total operative time (from skin incision to skin closure) and fascial closure time (from start to completion of the mesh-fascial suture line), both measured in minutes and recorded intraoperatively by the surgical team using the operating room clock.","Intraoperative (during the surgical procedure)",{"measure":23,"description":24,"timeFrame":25},"Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)","Self-reported postoperative pain intensity measured using the 11-point Numeric Pain Rating Scale (NRS-11), an unabbreviated verbally- or visually-administered numeric scale ranging from 0 to 10, where 0 indicates \"no pain\" and 10 indicates \"worst pain imaginable.\" Higher scores indicate worse (more severe) pain. Assessed at rest.","Postoperative days 7, 15, and 30",{"measure":27,"description":28,"timeFrame":29},"Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)","Proportion of participants with surgical site infection, seroma, wound dehiscence, or hematoma, identified by clinical examination at scheduled postoperative visits (days 7, 15, and 30) and graded according to the Clavien-Dindo classification.","Up to 30 days postoperative",{"measure":31,"description":32,"timeFrame":33},"Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations","Total direct hospital costs, expressed in Argentine pesos (ARS), attributable to management of complications or unplanned reoperations, extracted from institutional administrative and billing records. Exploratory outcome; not powered for formal statistical comparison between groups.","Up to 24 months (exploratory)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":41,"whoMasked":42},"SINGLE","When feasible, the ultrasound assessment used to determine hernia recurrence is performed by an evaluator independent of and unaware of the surgical technique assigned to the participant, in order to reduce outcome-assessment bias. Blinding of the participant, surgeon, and investigator is not feasible given the nature of the surgical intervention.",[43],"OUTCOMES_ASSESSOR","Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.\n\nThe Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure.\n\nThis is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos \"Dr. Mario V. Larrain,\" Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).\n\nThe study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Standard Mesh Closure","ACTIVE_COMPARATOR","Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture",[51],"Procedure: Standard Fascial Closure with Mesh",{"label":53,"type":54,"description":55,"interventionNames":56},"Integrated Mesh-Fascial Closure - IMFC","EXPERIMENTAL","Fascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh",[57],"Procedure: Integrated Mesh-Fascial Closure",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":34},"PROCEDURE","Integrated Mesh-Fascial Closure","Same materials integrated into a single continuous suture line using the IMFC technique.",[53],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":34},"Standard Fascial Closure with Mesh","Macroporous polypropylene mesh (FILAPROP™\u002FMERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique.",[47],[69],{"name":70,"affiliation":71,"role":72},"Facundo B Mattano, MD","Hospital Zonal General de Agudos \"Dr. Mario V. Larrain","PRINCIPAL_INVESTIGATOR",[74,78],{"name":70,"role":75,"phone":76,"phoneExt":34,"email":77},"CONTACT","+54 9 221 611-7976","mattanofacundo@outlook.com",{"name":79,"role":75,"phone":80,"phoneExt":34,"email":34},"Emiliano D Gargiulo, MD","+54 2215371371",[82],{"facility":71,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"RECRUITING","Berisso","Buenos Aires","1923","Argentina","AR",{"type":90,"coordinates":91},"Point",[92,93],-57.88328,-34.8715,{"lat":93,"lon":92},[96,98],{"name":70,"role":75,"phone":97,"phoneExt":34,"email":77},"+54 9 2216117976",{"name":79,"role":75,"phone":99,"phoneExt":34,"email":34},"+54 9 221 5371371",{"type":72,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Bovino Mattano Facundo","Surgeon (General Surgery), Urologist, Principal Investigator","100657582","standard-closure-vs-integrated-mesh-fascial-closure-imfc-for-incisional-hernia-repair-100657582",false,"NCT07843225","Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair","Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study","IMFC","Inclusion Criteria:\n\n* Adults older than 18 years of age\n* Patients with incisional (ventral) hernia\n* Patients with recurrent incisional hernia\n* Incisional hernias with a diameter greater than 4 cm\n* Patients undergoing laparotomy with an indication for prophylactic mesh placement\n\nExclusion Criteria:\n\n* Active surgical site infection\n* Overt abdominal contamination\n* Tissue necrosis or inability to achieve primary fascial closure\n* Non-correctable loss of domain\n* Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period\n* Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines\n* Active oncologic disease (patients with a cured oncologic history may be included)","ALL","18 Years",{"count":114,"type":115},60,"ESTIMATED","INTERVENTIONAL",[118],"NA","This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.\n\nIn one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, a new technique called Integrated Mesh-Fascial Closure (IMFC), developed by the research team, is used: the mesh is incorporated directly within the same continuous suture line that closes the abdominal wall, aiming to better distribute tension across the surgical wound.\n\nThe choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.",[121,122],"Incisional Hernia Repair","Ventral Incisional Hernia",[124,125,126,127,128,129,109],"incisional hernia","ventral hernia","surgical mesh","fascial closure","abdominal wall surgery","hernia recurrence","2026-09-29",{"date":132,"type":133},"2026-09-30","ACTUAL",{"date":135,"type":133},"2026-09-28",{"date":137,"type":115},"2032-10-15",{"name":5,"class":6},1]