[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557109":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Consorci Sanitari Integral","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IPST mesh placement","EXPERIMENTAL","A three-dimensional, funnel-shaped mesh will be used.",[13],"Procedure: Permanent colostomy",{"label":15,"type":16,"description":17,"interventionNames":18},"No mesh","ACTIVE_COMPARATOR","No mesh will be applied.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Permanent colostomy","A long-term (permanent) colostomy will be performed in the diseased colon or rectum.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Laura Sobrerroca Porras, MD","CONTACT","+34935531200","lsobrerrocap@csi.cat",[33],{"facility":34,"status":25,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital Sant Joan Despí Moisès Broggi","Sant Joan Despí","Barcelona","08970","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],2.0574,41.36718,{"lat":44,"lon":43},[47,48],{"name":28,"role":29,"phone":25,"phoneExt":25,"email":31},{"name":49,"role":29,"phone":25,"phoneExt":25,"email":50},"Jesús Badia Closa","jbadiac@csi.cat",{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100557109","prevention-of-parastomal-hernias-with-a-preformed-three-dimensional-funnel-shaped-mesh-100557109",false,"NCT06533839","Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh","Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)","PREVEMAC","Inclusion Criteria:\n\n* Patients undergoing a definitive colostomy confection\n* Terminal colostomy confection\n* ASA index III or inferior\n* Patients who have given legat authorization to participate in the study\n\nExclusion Criteria:\n\n* Lateral colostomy or a colostomy that will be removed posteriorly","ALL","18 Years",{"count":64,"type":65},58,"ESTIMATED","INTERVENTIONAL",[68],"NA","Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.\n\nVarious systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.\n\nThe aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.",[71],"Parastomal Hernia",[73,74,75],"Parastomal hernia","end colostomy","prophylactic mesh","NOT_YET_RECRUITING","2024-07-30",{"date":79,"type":80},"2024-08-01","ACTUAL",{"date":79,"type":65},{"date":83,"type":65},"2029-08-01",{"name":5,"class":6},1]