[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416172":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":78,"collaborators":82,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Hospital Universitari Joan XXIII de Tarragona.","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Prosthesis","EXPERIMENTAL","Firstly, a laparoscopic cholecystectomy is performed. After suturing the aponeurosis with a J needle and 0 Polydioxanone, a lightweight, large-pore mesh made of PVDF monofilament (polyvinylidene fluoride - DynaMesh-CICAT, FEC Textiltechnik, Germany) will be placed onlay, overlapping 2cm in all directions from the edge of the aponeurosis incision at the umbilical trocar site. The mesh will be fixed to the aponeurosis with cyanoacrylate glue (Glubran®, GEM, Viareggio, Italy).",[13,14,15],"Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure","Procedure: laparoscopic cholecystectomy","Diagnostic Test: Abdominal ultrasound",{"label":17,"type":18,"description":19,"interventionNames":20},"Control","ACTIVE_COMPARATOR","Firstly, a laparoscopic cholecystectomy is performed. Closure of the aponeurosis will be performed by standard procedure: under direct vision, suturing the aponeurosis with a J needle and 0 Polydioxanone, with a stitch interval of ≤ 5mm.",[14,15],[22,27,31],{"type":23,"name":24,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Hincisional hernia prevention by onlay prosthesis trocar closure",[9],null,{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"laparoscopic cholecystectomy","Laparoscopic cholecystectomy with or without common bile duct exploration",[17,9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DIAGNOSTIC_TEST","Abdominal ultrasound","Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery",[17,9],[37],{"name":38,"affiliation":39,"role":40},"Carles Olona Casas, MD","Hospital Universitari de Tarragona","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Joan Ferreres Serafini, MD","CONTACT","(+34) 657920793","joanfs8@gmail.com",{"name":48,"role":44,"phone":26,"phoneExt":26,"email":49},"Rosa Jorba Martin, MD","rjorba.hj23.ics@gencat.cat",[51,67],{"facility":52,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Hospital Universitari de Tarragona Joan XXIII","RECRUITING","Tarragona","43005","Spain","ES",{"type":59,"coordinates":60},"Point",[61,62],1.24544,41.11905,{"lat":62,"lon":61},[65],{"name":43,"role":44,"phone":66,"phoneExt":26,"email":46},"657920793",{"facility":68,"status":53,"city":69,"state":54,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Pius, Hospital de Valls","Valls","43800",{"type":59,"coordinates":72},[73,74],1.24993,41.28612,{"lat":74,"lon":73},[77],{"name":43,"role":44,"phone":66,"phoneExt":26,"email":46},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Joan Ferreres i Serafini","MD, 3rd year resident, General Surgery",[83,85],{"name":84,"class":6},"Institut de Diagnostic per la Imatge",{"name":86,"class":6},"Institut Investigacio Sanitaria Pere Virgili","100416172","trocar-site-incisional-hernia-prevention-100416172",false,"NCT04699201","Trocar Site Incisional Hernia Prevention","Prevenció De L'Hèrnia Incisional Per Tròcar","PHIT","Inclusion Criteria:\n\n* Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital\n* ASA (American Society of Anesthesiologists) \\\u003CIV\n\nExclusion Criteria:\n\n* Allergy or intolerance to any of the mesh components\n* Patients presenting already primary or incisional hernia of the abdominal wall\n* ASA ≥IV\n* Intraoperative conversion to laparotomy\n* Emergency surgery\n* Pregnancy",true,"ALL","18 Years","99 Years",{"count":100,"type":101},94,"ESTIMATED","INTERVENTIONAL",[104],"NA","Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery.\n\nMethods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months.\n\nAn ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination.\n\nRelevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique.\n\nThere are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.",[107],"Incisional Hernia",[109],"Incisional Hernia, Umbilical Trocar, Preventive mesh","2024-10-01",{"date":112,"type":113},"2024-10-02","ACTUAL",{"date":115,"type":113},"2021-03-02",{"date":117,"type":101},"2025-02",{"name":5,"class":6},2]