[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511457":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":47,"responsibleParty":62,"collaborators":30,"id":66,"slug":30,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Blokhin's Russian Cancer Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"mesh","EXPERIMENTAL","In these patients we will do sublay\u002Finteroblique repair for prevention of stoma-site hernias using a polypropylene mesh.",[13],"Procedure: mesh",{"label":15,"type":16,"description":17,"interventionNames":18},"non-mesh","ACTIVE_COMPARATOR","In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.",[19],"Procedure: non-mesh",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","We'll use mesh repair for prevention of stoma-site hernias in the study group.",[9],[26],"polypropylene mesh",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.",[15],null,[32,36],{"name":33,"affiliation":34,"role":35},"Zaman Z Mamedli, PhD","N.N.Blokhin Russian Cancer Research Center","STUDY_DIRECTOR",{"name":37,"affiliation":38,"role":39},"Nikolay L Matveev, PhD","Pirogov Russian National Research Medical University","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Sergey Gordeyev, D.Sc.","CONTACT","9104501213","007","ss.netoncology@gmail.com",[48],{"facility":34,"status":49,"city":50,"state":30,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Moscow","115478","Russia",{"type":54,"coordinates":55},"Point",[56,57],37.61781,55.75204,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":44,"phoneExt":45,"email":46},"Sergey S Gordeyev, PhD",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Sergey Gordeyev","Principal investigator, Department of Colorectal surgery","100511457",false,"NCT05939687","Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection","Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial","ProMeLAR","Inclusion Criteria:\n\n* Signed informed consent\n* Absence of distant metastases (M0)\n* ECOG (Eastern Cooperative Oncology Group) status 0-2\n* completed course of adjuvant treatment\n* Absence of acute inflammatory parastomal complications\n* Integrity of colorectal anastomosis\n\nExclusion Criteria:\n\n* Inability to obtain consent to participate\n* Synchronous and metachronous malignant neoplasms\n* Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system\n* Parastomal inflammation and other conditions that increase the risk of postoperative complications\n* Pregnancy\n* HIV infection","ALL","18 Years","85 Years",{"count":77,"type":78},142,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.\n\nResearchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.",[84,85,86,87],"Neoplasms Malignant","Rectal Cancer","Hernia Incisional","Surgery",[89,9,90,91,92],"Rectal cancer","stoma-site hernia","prevention","surgery","2024-08-06",{"date":95,"type":96},"2024-08-07","ACTUAL",{"date":98,"type":96},"2023-06-05",{"date":100,"type":78},"2028-12-01",{"name":5,"class":6},1]