[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660005":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":66,"studyPopulation":66,"armGroups":73,"interventions":80,"overallOfficials":86,"centralContacts":91,"locations":100,"responsibleParty":119,"collaborators":66,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":66,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":66,"enrollmentInfo":131,"targetDuration":66,"studyType":134,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":146,"whyStopped":66,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Corewell Health West","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Incisional Hernia at the Loop Ileostomy Closure Site","Development of an incisional hernia at the loop ileostomy closure site, confirmed by CT imaging.","2 years after loop ileostomy closure",[14,18,22,26,30,33,37,40,43,47,50,53,56,59,63],{"measure":15,"description":16,"timeFrame":17},"Operative Time","Duration of the loop ileostomy closure procedure","During surgery",{"measure":19,"description":20,"timeFrame":21},"Blood Transfusions","Occurrence of blood transfusion associated with the loop ileostomy closure procedure.","Perioperative\u002FPeriprocedural",{"measure":23,"description":24,"timeFrame":25},"Surgical Site Infection","Occurrence of surgical site infection following loop ileostomy closure.","Within 30 days after surgery",{"measure":27,"description":28,"timeFrame":29},"Postoperative Morbidity","Postoperative mobidity assessed using the Clavien-Dindo Classification.","Through 6 weeks after surgery",{"measure":31,"description":32,"timeFrame":29},"Postoperative Mortality","Occurrence of death following loop ileostomy closure.",{"measure":34,"description":35,"timeFrame":36},"Hospital Length of Stay","Number of das hospitalized following loop ileostomy closure.","Up to 6 weeks after surgery",{"measure":38,"description":39,"timeFrame":36},"ICU Length of Stay","Number of days spent in the intesive care unit following loop ileostomy closure, if applicable.",{"measure":41,"description":42,"timeFrame":29},"Reoperation","Occurrence of reoperation following loop ileostomy closure.",{"measure":44,"description":45,"timeFrame":46},"Hospital Readmission","Occurence of hospital readmission folloing loop ileostomy closure.","30, 60, and 90 days after surgery",{"measure":48,"description":49,"timeFrame":29},"Seroma","Occurence of seroma associated with the mesh-reinforced loop ileostomy closure site.",{"measure":51,"description":52,"timeFrame":29},"Hematoma","Occurrence of hematoma associated with the mesh-reinforced loop ileostomy closure site.",{"measure":54,"description":55,"timeFrame":29},"Mesh-Related Infection","Occurence of infection associated with the mesh-reinforced loop ileostomy closure site.",{"measure":57,"description":58,"timeFrame":29},"Mesh-Related Reoperation","Occurence of reoperation related to the mesh-reinforced loop ileostomy closure site.",{"measure":60,"description":61,"timeFrame":62},"Health-Related Quality of Life (SF-36)","Self-reported health-related quality of life assessed using the Short Form-36 (SF-36) questionnaire.","Preoperative visit, 6 weeks after surgery, and 2 years after surgery",{"measure":64,"description":65,"timeFrame":62},"Activity Level (Activities Assessent Scale)","Self-reported activity level assessed using the Activities Assessment Scale (AAS) questionnaire.",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NA","SINGLE_GROUP","PREVENTION",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE",[74],{"label":75,"type":76,"description":77,"interventionNames":78},"Phasix Mesh Reinforced Closure","EXPERIMENTAL","Participants undergoing loop ileostomy closure will receive prophylactic long-acting absorbable Phasix mesh reinforcement at the ileostomy closure site.",[79],"Device: Long-acting absorbable mesh",[81],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":66},"DEVICE","Long-acting absorbable mesh","Lon-acting absorbable Phasix mesh is placed in the retro-rectus space during loop ileostomy closure to reinforce the closure site. The posterior rectus sheath is closed prior to mesh placement, and the mesh is not fixated to surrounding tissue. If the posterior rectus sheath is not intact or cannot be closed, mesh-reinforced closure is not performed and standard primary closure with suture is used.",[75],[87],{"name":88,"affiliation":89,"role":90},"James Ogilvie, MD","Corewell Health","PRINCIPAL_INVESTIGATOR",[92,97],{"name":93,"role":94,"phone":95,"phoneExt":66,"email":96},"Kendra Selby","CONTACT","616-486-0281","kendra.selby@helendevoschildrens.org",{"name":98,"role":94,"phone":66,"phoneExt":66,"email":99},"Ellie Poll","elise.poll@corewellhealth.org",[101],{"facility":5,"status":66,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Grand Rapids","Michigan","49546","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-85.66809,42.96336,{"lat":111,"lon":110},[114,116,117],{"name":115,"role":94,"phone":95,"phoneExt":66,"email":96},"Kendra Selby, RRT",{"name":98,"role":94,"phone":66,"phoneExt":66,"email":99},{"name":118,"role":90,"phone":66,"phoneExt":66,"email":66},"James Ogilvie, Jr., MD",{"type":90,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"James W. Ogilvie","Principal Investigator","100660005","phasix-mesh-underlay-during-loop-ileostomy-closure-100660005",false,"NCT07871630","Phasix Mesh Underlay During Loop Ileostomy Closure","Phasix Mesh Underlay During Loop Ileostomy Closure: A Single Center Prospective Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* History of creation of a loop ileostomy\n* Presenting for loop ileostomy closure\n* BMI greater than 25\n\nExclusion Criteria:\n\n* Patients involved in other clinical research trials\n* Unable to close posterior rectus sheath\n* Cannot consent or are unwilling to consent\n* Belong to a vulnerable population group such as pediatric patients, prisoners, pregnant patients, individuals with limited English proficiency, visually impaired individuals, or non-readers\n* Patients with prohibitive medical risk including congestive heart failure, renal failure, or liver failure, based on the discretion of the principal investigator and operating surgeon\n* Allergy to tetracycline hydrochloride or kanamycin sulfate\n* Women planning to become pregnant during study participation has context menu","ALL","18 Years",{"count":132,"type":133},65,"ESTIMATED","INTERVENTIONAL",[68],"This prospective study will evaluate whether placement of long-acting absorbable Phasix mesh during loop ileostomy closure reduces the development of an incisional hernia at the ileostomy closure site in patients with a BMI greater than 25. Participants will undergo mesh-reinforced closure and will be followed for two years after surgery. The primary outcome is development of an incisional hernia at the ileostomy closure site, confirmed by CT imaging at two years.",[138],"Incisional Hernia of Anterior Abdominal Wall",[140,141,142,143,144,145],"Loop ileostomy closure","Phasix mesh","prophylactic mesh","Mesh reinforcement","Ileostomy site hernia","Incisional Hernia","NOT_YET_RECRUITING","2026-10-08",{"date":149,"type":150},"2026-10-13","ACTUAL",{"date":152,"type":133},"2026-10-30",{"date":154,"type":133},"2028-10-30",{"name":5,"class":6},1]