[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487562":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":48,"centralContacts":53,"locations":63,"responsibleParty":121,"collaborators":124,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":39,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":66,"whyStopped":39,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",[8,14,19,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"IPAA CRUISE","EXPERIMENTAL","Patients eligible for both operations choosing ileal pouch anal anastomosis.",[13],"Procedure: Ileal pouch anal anastomosis (IPAA)",{"label":15,"type":10,"description":16,"interventionNames":17},"IRA CRUISE","Patients eligible for both operations choosing ileorectal anastomosis.",[18],"Procedure: Ileorectal anastomosis (IRA)",{"label":20,"type":21,"description":22,"interventionNames":23},"IRA Control","ACTIVE_COMPARATOR","Patients only eligible for ileorectal anastomosis.",[18],{"label":25,"type":21,"description":26,"interventionNames":27},"IPAA Control","Patients only eligible for ileal pouch anal anastomosis.",[13],{"label":29,"type":21,"description":30,"interventionNames":31},"Ileostomy Control","Patients who decline reconstruction.",[32],"Procedure: ileostomy",[34,40,44],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"PROCEDURE","Ileorectal anastomosis (IRA)","After subtotal colectomy for ulcerative colitis the patients can either keep their end ileostomy or be reconstructed with an anastomosis (connection) between the ileum and the rectal remnant (Ileorectal anastomosis(IRA))",[15,20],null,{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Ileal pouch anal anastomosis (IPAA)","The rectum is removed and a pouch constructed with the distal part opf the ileum which in subsequently anastomosed (connected) to the anus(Ileal pouch anal anastomosis (IPAA)).",[9,25],{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":39},"ileostomy","no reconstruction is performed and the patient is left with his\u002Fher ileostomy",[29],[49],{"name":50,"affiliation":51,"role":52},"Caroline Nordenvall, Ass. Prof","Karolinska Institutet","STUDY_CHAIR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":39,"email":58},"Anton Risto","CONTACT","0702510374","anton.risto@liu.se",{"name":60,"role":56,"phone":61,"phoneExt":39,"email":62},"Pär Myrelid, Prof.","+46 0 10 1031581","par.myrelid@liu.se",[64,81,94,107],{"facility":65,"status":66,"city":67,"state":39,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Sahlgrenska Univercity Hospital","RECRUITING","Gothenburg","SE-413 45","Sweden","SE",{"type":72,"coordinates":73},"Point",[74,75],11.96679,57.70716,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":80,"phoneExt":39,"email":39},"Maria Hermansson","+46 0 76 0401039",{"facility":82,"status":66,"city":83,"state":39,"zip":84,"country":69,"countryCode":70,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Linkoeping University hospital","Linköping","58731",{"type":72,"coordinates":86},[87,88],15.62157,58.41086,{"lat":88,"lon":87},[91,92],{"name":55,"role":56,"phone":57,"phoneExt":39,"email":58},{"name":93,"role":56,"phone":39,"phoneExt":39,"email":39},"Pär Myrelid",{"facility":95,"status":66,"city":96,"state":39,"zip":97,"country":69,"countryCode":70,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Karolinska University Hospital","Solna","se-171 76",{"type":72,"coordinates":99},[100,101],18.00086,59.36004,{"lat":101,"lon":100},[104],{"name":105,"role":56,"phone":106,"phoneExt":39,"email":39},"Caroline Nordenvall","+46 0 70 6579109",{"facility":108,"status":66,"city":109,"state":39,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"St. Mark's Hospital","London","HA1 3UJ","United Kingdom","UK",{"type":72,"coordinates":114},[115,116],-0.12574,51.50853,{"lat":116,"lon":115},[119],{"name":120,"role":56,"phone":39,"phoneExt":39,"email":39},"Mohammed Deputy",{"type":122,"investigatorFullName":55,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Principal investigator",[125,127,129],{"name":95,"class":126},"OTHER",{"name":128,"class":126},"Göteborg University",{"name":130,"class":126},"University College London Hospitals","100487562","colectomy-reconstruction-for-ulcerative-colitis-ileorectal-anastomosis-vs-ileal-pouch-anal-anastomosis-in-ulcerative-colitis-100487562",false,"NCT05628701","Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.","Colectomy Reconstruction for Ulcerative Colitis In Sweden and England: a Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy in Patients With Ulcerative Colitis.","CRUISE","Inclusion criteria:\n\n* Patients with Ulcerative colitis (UC) aged between 18 and 60\n* Scheduled for or have previously undergone subtotal colectomy and ileostomy.\n* Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical Mezalasin only.\n\nExclusion criteria\n\n* Rectal inflammation of Mayo Score \\>1\n* Poor sphincter function, perianal disease\n* Uncertainty regarding UC diagnosis P\n* Previous colorectal cancer or severe dysplasia\n* Primary Sclerosing Colitis diagnosis\n* \\>2 year since subtotal colectomy","ALL","18 Years","60 Years",{"count":143,"type":144},100,"ESTIMATED","INTERVENTIONAL",[147],"NA","Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves.\n\nMethods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis.\n\nDiscussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.",[150,151,152],"Ulcerative Colitis","Inflammatory Bowel Diseases","Ileostomy - Stoma",[154,155,156],"Ulcerative Colitis,","Colectomy","Reconstruction","2022-11-16",{"date":159,"type":160},"2022-11-29","ACTUAL",{"date":162,"type":160},"2017-04-04",{"date":164,"type":144},"2029-12-31",{"name":5,"class":6},4]