[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511457":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":47,"responsibleParty":63,"collaborators":30,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":49,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Moscow","115478","Russia","RU",{"type":55,"coordinates":56},"Point",[57,58],37.61781,55.75204,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":44,"phoneExt":45,"email":46},"Sergey S Gordeyev, PhD",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Sergey Gordeyev","Principal investigator, Department of Colorectal surgery","100511457","phase-3-prophylactic-mesh-placement-during-stoma-closure-after-low-anterior-resection-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":79,"type":80},142,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86,87,88,89],"Neoplasms Malignant","Rectal Cancer","Hernia Incisional","Surgery",[91,9,92,93,94],"Rectal cancer","stoma-site hernia","prevention","surgery","2024-08-06",{"date":97,"type":98},"2024-08-07","ACTUAL",{"date":100,"type":98},"2023-06-05",{"date":102,"type":80},"2028-12-01",{"name":5,"class":6},1]