[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643906":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":34,"locations":35,"responsibleParty":81,"collaborators":34,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":34,"enrollmentInfo":94,"targetDuration":34,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":106,"whyStopped":34,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Hospital do Divino Espírito Santo de Ponta Delgada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Regimen A","ACTIVE_COMPARATOR","2-L split-dose PEG + 1-day low-fibre diet + clear liquids on the afternoon before colonoscopy",[13],"Drug: 2-L PEG plus 1-day low fibre diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Regimen B","EXPERIMENTAL","2-L split-dose PEG + 15 mg bisacodyl + 3-day low fibre diet + clear liquids on the day before colonoscopy",[19],"Drug: 2-L PEG plus bisacodyl plus 3-day low fibre diet",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","2-L PEG plus bisacodyl plus 3-day low fibre diet","2-L split-dose polyethylene glycol combined with 15 mg bisacodyl the afternoon before colonoscopy, a 3-day low-fibre diet, and clear liquids the day before colonoscopy",[15],[27,28],"Bisacodyl","Cleansia",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"2-L PEG plus 1-day low fibre diet","2-L split-dose polyethylene glycol bowel preparation combined with a 1-day low-fibre diet and clear liquids the afternoon before colonoscopy",[9],[28],null,[36,49,63,72],{"facility":37,"status":34,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":34},"Hospital Central do Funchal, SESARAM","Funchal","Madeira","9004-514","Portugal","PT",{"type":44,"coordinates":45},"Point",[46,47],-16.92547,32.66568,{"lat":47,"lon":46},{"facility":5,"status":34,"city":50,"state":51,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Ponta Delgada","São Miguel","9500-370",{"type":44,"coordinates":54},[55,56],-25.66874,37.73952,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":34,"phoneExt":34,"email":62},"Nadine Amaral","CONTACT","nadine.amaral8@gmail.com",{"facility":64,"status":34,"city":65,"state":34,"zip":66,"country":41,"countryCode":42,"cosmosGeoPoint":67,"geoPoint":71,"contacts":34},"ULS de Coimbra","Coimbra","3004-561",{"type":44,"coordinates":68},[69,70],-8.41996,40.20686,{"lat":70,"lon":69},{"facility":73,"status":34,"city":74,"state":34,"zip":75,"country":41,"countryCode":42,"cosmosGeoPoint":76,"geoPoint":80,"contacts":34},"ULS da Arrábida","Setúbal","2910-446",{"type":44,"coordinates":77},[78,79],-8.8882,38.5244,{"lat":79,"lon":78},{"type":82,"investigatorFullName":60,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100643906","phase-3-evaluation-of-a-modified-bowel-preparation-regimen-in-cirrhotic-patients-undergoing-colonoscopy-100643906",false,"NCT07668778","Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy","Evaluation of a Modified Bowel Preparation Regimen in Cirrhotic Patients Undergoing Colonoscopy: a Multicentre Randomized Controlled Trial","CIRRHOPREP","Inclusion Criteria:\n\n* Established diagnosis of cirrhosis, scheduled for elective outpatient total colonoscopy\n* Age ≥ 18 years\n* Ability to follow verbal and written instructions in Portuguese\n\nExclusion Criteria:\n\n* Urgent procedures\n* Colonoscopies not intended to reach the caecum\n* History of any colonic surgery\n* Absolute contraindication to bowel preparation or colonoscopy\n* Active hepatic encephalopathy (West Haven grade ≥2) at the time of enrolment\n* Refractory ascites, defined as ascites unresponsive to maximum diuretic therapy or requiring repeated large-volume paracentesis\n* Severe hyponatraemia (serum sodium \\\u003C125 mEq\u002FL) at the time of enrolment\n* Subject refusal or inability to comprehend the trial","ALL","18 Years",{"count":95,"type":96},252,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","Inadequate bowel preparation compromises colonoscopy quality and diagnostic accuracy, and cirrhosis is a recognized independent predictor of poor bowel cleansing. However, no bowel preparation regimen has been prospectively validated or specifically tailored for cirrhotic patients.\n\nThis multicenter, prospective, randomized, single-blind controlled clinical trial will evaluate whether the addition of adjunctive measures as an intensified bowel preparation protocol improves bowel cleansing quality in adult patients with cirrhosis undergoing elective outpatient colonoscopy.\n\nParticipants will be randomized 1:1 to receive either a standard bowel preparation protocol, consisting of a 2-litre split-dose polyethylene glycol (PEG) regimen combined with a one-day low-residue diet and clear liquids the afternoon before the procedure (control), or the same split-dose regimen with the assigned adjunctive measures: 15 mg bisacodyl, a 3-day low-residue diet, and clear liquids the day before colonoscopy (intervention).\n\nThe primary outcome is the proportion of patients achieving adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥6 with no individual segment score \\\u003C2. Secondary outcomes include polyp, adenoma, advanced adenoma and colorectal cancer detection rates, caecal intubation rate, patient compliance, tolerability, and adverse events. Pre-specified subgroup analyses will evaluate the influence of etiology and severity of cirrhosis and portal hypertension complications.\n\nBy addressing a critical and unmet clinical need, this trial aims to generate high-quality evidence to optimize bowel preparation strategies in patients with cirrhosis, improve colonoscopy quality, and ultimately enhance colorectal cancer screening outcomes in this vulnerable population.",[102,103],"Cirrhosis","Bowel Preparation",[105,102],"Inadequate bowel preparation","NOT_YET_RECRUITING","2026-06-23",{"date":109,"type":110},"2026-06-25","ACTUAL",{"date":112,"type":96},"2026-08-01",{"date":114,"type":96},"2027-10-30",{"name":5,"class":6},4]