[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652339":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":52,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Linkoeping","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"5-ASA","EXPERIMENTAL","5-ASA suppositories",[13],"Drug: 5-ASA",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo suppositories",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Topical prophylactic treatment of pouchitis after restorative proctocolectomy",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Topical placebor after restorative påroctocolectomy",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Pär Myrelid, Prof, MD, PhD","CONTACT","+46101031581","par.myrelid@liu.se",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"Linköping University Hospital","Linköping","58185","Sweden","SE",{"type":43,"coordinates":44},"Point",[45,46],15.62157,58.41086,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Pär Myrelid","Prof",[53,55,57,59,61,63,65,67],{"name":54,"class":6},"Karolinska University Hospital",{"name":56,"class":6},"Skane University Hospital",{"name":58,"class":6},"Region Örebro County",{"name":60,"class":6},"Örebro University, Sweden",{"name":62,"class":6},"Karolinska Institutet",{"name":64,"class":6},"Östra Hospital",{"name":66,"class":6},"Göteborg University",{"name":68,"class":6},"Lund University","100652339","phase-4-asapp-study---topical-5-asa-as-prophylaxis-for-pouchitis-in-ulcerative-colitis-patients-after-pelvic-pouch-surgery-100652339",false,"NCT07773948","ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery","ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery, a Double Blinded Randomized Controlled Trial","ASAPP","Inclusion Criteria:\n\n* Adult patients with UC who are planned for reconstruction with IPAA. All four Swedish units with a national license to perform restorative surgery in IBD will be recruiting patients.\n\nExclusion Criteria:\n\n* Patients with concomitant primary sclerosing cholangitis (PSC) or previous intolerance to 5-ASA will be excluded.","ALL","18 Years","70 Years",{"count":81,"type":82},110,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","Ulcerative colitis (UC) is a chronic intestinal disease, often debuting early in life, and affecting the colon and rectum. The therapy is mainly medical and based on 5-aminosalicylic acid (5-ASA) and steroids. The last 20 years numerous new advanced therapies have become available and introduced more and more early after diagnosis. Surgery is still needed in refractory disease and will cure most patients, while ending up with a stoma. There is conflicting data on whether advanced therapies are decreasing the need for surgery or not.\n\nReconstruction of bowel continuity is usually possible but somehow performed in less than 50% of Swedish patients. Restorative proctectomy with ileal pouch (created of the last part of the small bowel) anal anastomosis (IPAA) is gold standard. As of this year it is centralized to 4 units in Sweden.\n\nOne complication after IPAA is pouchitis, an inflammation in the pouch that behaves like UC. More than half of all patients will have at least one flare of pouchitis, and some will develop chronic or recurrent pouchitis. Recent publications have shown an increased risk of pouchitis after the introduction of advanced therapies, but the reasons for this are still unknown. Prophylactic therapy with 5-ASA after IPAA surgery have been suggested.\n\nAll patients in Sweden going through IPAA surgery due to UC will be invited to be part of this randomized controlled study to evaluate if 5-ASA can diminish the risk of pouchitis in UC.",[88,89],"Ulcerative Colitis (UC)","Pouchitis",[91,92],"Restorative proctocolectomy","Pelvic pouch","NOT_YET_RECRUITING","2026-08-14",{"date":96,"type":97},"2026-08-19","ACTUAL",{"date":99,"type":82},"2027-04-01",{"date":101,"type":82},"2031-03-31",{"name":5,"class":6},1]