[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495100":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":87,"collaborators":91,"id":98,"slug":18,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":18,"enrollmentInfo":107,"targetDuration":18,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":122,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunonutrition","EXPERIMENTAL","Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition",[13],"Drug: Immunonutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"No immunonutrition (control)","NO_INTERVENTION","Standard of care",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","Immunonutrition: Oral Impact®, Nestlé Health Science, Switzerland.\n\nIN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact® is a powdered oral feed that provides 309 kcal\u002Fbag",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Ilaria Lucca, MD","CONTACT","+41213142980","ilaria.lucca@chuv.ch",[31,50,62,75],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Centre Hospitalier Universitaire Vaudois, CHUV","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":40,"coordinates":41},"Point",[42,43],6.63282,46.516,{"lat":43,"lon":42},[46,47],{"name":26,"role":27,"phone":18,"phoneExt":18,"email":29},{"name":48,"role":27,"phone":18,"phoneExt":18,"email":49},"François Crettenand, MD","francois.crettenand@chuv.ch",{"facility":51,"status":33,"city":52,"state":18,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"University Hospital of Bern","Bern",{"type":40,"coordinates":54},[55,56],7.44744,46.94809,{"lat":56,"lon":55},[59],{"name":60,"role":27,"phone":18,"phoneExt":18,"email":61},"Beat Roth, MD","beat.roth@insel.ch",{"facility":63,"status":33,"city":64,"state":18,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University Hospital of Geneva","Geneva",{"type":40,"coordinates":66},[67,68],6.14569,46.20222,{"lat":68,"lon":67},[71],{"name":72,"role":27,"phone":73,"phoneExt":18,"email":74},"Philippe Sebe, Prof","+41223723311","philippe.sebe@hug.ch",{"facility":76,"status":33,"city":77,"state":18,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hospital of Riviera-Chablais","Rennaz",{"type":40,"coordinates":79},[80,81],6.91604,46.3748,{"lat":81,"lon":80},[84],{"name":85,"role":27,"phone":18,"phoneExt":18,"email":86},"Thomas Tawadros, PhD","thomas.tawadros@rivierachablais.ch",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ilaria Lucca","MD, Principal Investigator",[92,94,96],{"name":93,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":95,"class":6},"Hôpital Riviera-Chablais, Vaud-Valais",{"name":97,"class":6},"University Hospital, Geneva","100495100",false,"NCT05726786","The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)","The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)","INCyst","Inclusion Criteria:\n\n* Patient undergoing open cystectomy (for all reasons)\n* Age ≥18 years\n* Ability and willingness to provide informed consent documented by signature\n\nExclusion Criteria:\n\n* Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin\n* Severe diarrhoea requiring medical attention\n* Current treatment with any immunosuppressive drug\n* In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV\n* Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)\n* Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study\n* Previous enrolment into the current study\n* Use of IN independently of the study\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons\n* Emergency procedure (less than 7 days between screening and surgery)","ALL","18 Years",{"count":108,"type":109},232,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy.\n\nAs a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.\n\nThis is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.",[115,116,117,118,119,120,121],"Bladder Cancer","Interstitial Cystitis","Painful Bladder Syndrome","Neurogenic Bladder","Hemorrhagic Cystitis","Endometriosis","Bladder Disease",[123,9,124,125],"Cystectomy","Complication","Malnutrition","2025-12-02",{"date":128,"type":129},"2025-12-09","ACTUAL",{"date":131,"type":129},"2023-04-10",{"date":133,"type":109},"2026-10",{"name":5,"class":6},4]