[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655559":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":76,"studyPopulation":66,"armGroups":77,"interventions":90,"overallOfficials":103,"centralContacts":111,"locations":119,"responsibleParty":147,"collaborators":66,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":158,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":66,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":174,"overallStatus":182,"whyStopped":66,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Westmead Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Final total Boston Bowel Preparation Scale (BBPS) score on blinded external image and video review","Sum of the segmental BBPS scores for the right, transverse and left colon (range 0-9, higher scores indicate better cleansing), determined by external expert reviewers masked to allocation from de-identified images and video of the withdrawal phase.","During colonoscopy withdrawal (single procedure)",[14,17,20,24,27,30,33,36,40,43,46,49,52,55,58,62],{"measure":15,"description":16,"timeFrame":12},"Segmental Boston Bowel Preparation Scale scores on blinded external image and video review","BBPS score for each colonic segment (right, transverse and left colon), each scored 0-3, determined by external expert reviewers masked to allocation from de-identified images and video of the withdrawal phase.",{"measure":18,"description":19,"timeFrame":12},"Proportion of participants achieving adequate bowel preparation","Proportion of participants with a total BBPS of 6 or more with each segmental score of 2 or more, on blinded external video review.",{"measure":21,"description":22,"timeFrame":23},"Adenoma detection rate","Proportion of participants with at least one histologically confirmed conventional adenoma in any colonic segment.","From colonoscopy until histopathology results are available, up to 4 weeks",{"measure":25,"description":26,"timeFrame":23},"Proximal adenoma detection rate","Proportion of participants with at least one histologically confirmed conventional adenoma proximal to the splenic flexure.",{"measure":28,"description":29,"timeFrame":23},"Sessile serrated lesion detection rate, overall","Proportion of participants with at least one histologically confirmed sessile serrated lesion in any segment",{"measure":31,"description":32,"timeFrame":23},"Sessile serrated lesion detection rate, proximal","Proportion of participants with at least one histologically confirmed sessile serrated lesion proximal to the splenic flexure.",{"measure":34,"description":35,"timeFrame":23},"Polyp detection rate","Proportion of participants with at least one polyp of any histology detected per colonoscopy.",{"measure":37,"description":38,"timeFrame":39},"Operator-recorded total BBPS compared with blinded external video review","Total BBPS recorded by the proceduralist at the end of the examination, compared with the corresponding scores from blinded external video review.","During colonoscopy (single procedure)",{"measure":41,"description":42,"timeFrame":39},"Operator-recorded Right Colon BBPS at first inspection compared with blinded external video review","Right colon BBPS recorded by the proceduralist at first inspection after caecal intubation compared with the corresponding scores from blinded external video review.",{"measure":44,"description":45,"timeFrame":39},"Intra-procedural water volume","Total volume of water used during the examination, calculated as the filled water-jet bottle volume minus the residual volume, recorded separately from the volume of instilled study agent",{"measure":47,"description":48,"timeFrame":23},"Adenomas per colonoscopy","Proportion of participants with at least adenomatous polyp; mean number of adenomas per colonoscopy.",{"measure":50,"description":51,"timeFrame":23},"Serrated polyps per colonoscopy","Proportion of participants with at least one serrated polyp; mean number of sessile serrated lesions per colonoscopy.",{"measure":53,"description":54,"timeFrame":39},"Total Procedure Time","Total time from endoscope insertion to endoscope withdrawal per procedure.",{"measure":56,"description":57,"timeFrame":39},"Withdrawal Time","Total withdrawal time from caecum to endoscope removal.",{"measure":59,"description":60,"timeFrame":61},"Need for early repeat colonoscopy due to inadequate preparation","Proportion of participants for whom an early repeat colonoscopy is booked or performed because of inadequate bowel preparation, ascertained by structured medical record review.","7 days after colonoscopy",{"measure":63,"description":64,"timeFrame":65},"Immediate and delayed adverse events","Immediate adverse events recorded in the recovery area, and delayed adverse events within 7 days ascertained by structured medical record review, including emergency department presentations, unplanned admissions, abdominal pain requiring medical evaluation, bleeding and perforation.","From colonoscopy to 7 days after the procedure",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":72,"maskingDescription":73,"whoMasked":74},"SINGLE","Endoscopists performing the procedure cannot be masked. The withdrawal phase of every colonoscopy is video-recorded, de-identified and edited to remove any indication of allocation before review. Segmental and total BBPS are scored by external expert reviewers who are masked to allocation and are not involved in performing the study procedures. Statistical analysis is performed masked to allocation.",[75],"OUTCOMES_ASSESSOR","Adequate mucosal visualisation in the right colon remains a limitation of colonoscopy despite standard oral bowel preparation, and residual debris in the caecum and ascending colon is associated with reduced adenoma detection and shortened surveillance intervals.\n\nRIGHT-CLEAN is an investigator-initiated, multi-centre, randomised controlled trial conducted at Westmead Hospital and Auburn Hospital within Western Sydney Local Health District. Adults undergoing colonoscopy for \\[indication\\] will be randomised \\[1:1\\] to intraprocedural right colon enema or to standard colonoscopy without enema. Randomisation will be \\[method, stratified by site\\].\n\nThe primary outcome is \\[right-sided Boston Bowel Preparation Scale segment score\\]. Secondary outcomes include \\[adenoma detection rate, caecal intubation and withdrawal times, need for additional washing, and participant-reported tolerability\\]. Assessment of cleanliness will be performed \\[by blinded assessors \u002F from recorded still images\\]. A sample size of \\[n\\] participants provides \\[x\\]% power to detect \\[effect size\\] at a two-sided alpha of 0.05.\n\nAll participants will provide written informed consent. No investigational drug or device is used; the enema comprises \\[water\u002Fsaline\\] administered through the colonoscope during the procedure.",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"Intra-procedural right colon Fleet enema","EXPERIMENTAL","Immediately after confirmed caecal intubation and randomisation, with the colonoscope tip in the right colon, a Fleet sodium phosphate enema is instilled into the right colon through the colonoscope working channel. The right colon is then refilled to the hepatic flexure using the foot-pump water jet. The fluid is not suctioned; the right lower quadrant is agitated by manual percussion. The lumen is re-insufflated with CO2 and the scope returned to the caecum before withdrawal begins, allowing the instilled solution and mobilised faecal residue to be carried distally through the transverse and left colon.",[83],"Drug: Sodium phosphate enema",{"label":85,"type":86,"description":87,"interventionNames":88},"Water control","PLACEBO_COMPARATOR","Colonoscopy lets doctors look inside the large bowel to find and remove growths called polyps. Before the test, people take a bowel preparation to empty the bowel, but the right side of the bowel is often still not clean enough, and polyps there can be missed.\n\nThis study is testing whether a small enema given through the colonoscope into the right side of the bowel, during the procedure, makes the whole bowel cleaner. Once the camera reaches the far end of the bowel, participants are assigned by chance to receive either the enema or the same volume of water. Everything else about the procedure is the same in both groups, and no extra preparation is taken at home.\n\nThe recordings of each procedure are reviewed by independent experts who do not know which group the participant was in, and who score how clean each part of the bowel was. The researchers will also compare how many polyps were found in each group.",[89],"Other: Water instillation",[91,99],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"DRUG","Sodium phosphate enema","A single Fleet sodium phosphate enema (monobasic sodium phosphate monohydrate 19 g and dibasic sodium phosphate heptahydrate 7 g in 118 mL of saline) is administered once, intra-procedurally, into the right colon through the colonoscope working channel after confirmed caecal intubation. The enema nozzle is aligned with the working channel for delivery. The volume instilled is recorded and is not counted towards intra-procedural water-jet lavage. No further doses are given.",[79],[97,98],"Fleet enema","Monobasic sodium phosphate monohydrate \u002F dibasic sodium phosphate heptahydrate",{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":66},"Water instillation","Immediately after confirmed caecal intubation and randomisation, with the colonoscope tip in the right colon, 100 mL of water is instilled into the right colon through the colonoscope working channel using a syringe. All subsequent steps are identical to the intervention arm: the right colon is refilled to the hepatic flexure using the foot-pump water jet, the fluid is not suctioned, the right lower quadrant is agitated by manual percussion, and the lumen is re-insufflated with CO2 before the scope is returned to the caecum for withdrawal.",[85],[104,108],{"name":105,"affiliation":106,"role":107},"Michael J Bourke, MBBS,FRACP","Westmead Hospita, Endoscopy Unit","STUDY_DIRECTOR",{"name":109,"affiliation":106,"role":110},"Nicholas G Burgess, MBChB, PhD, FRACP","PRINCIPAL_INVESTIGATOR",[112,116],{"name":109,"role":113,"phone":114,"phoneExt":66,"email":115},"CONTACT","+61 2 9845 5881","Nicholas.Burgess@health.nsw.gov.au",{"name":117,"role":113,"phone":114,"phoneExt":66,"email":118},"Mayan Eitan, M.D","mayania9@gmail.com",[120,136],{"facility":121,"status":66,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"Auburn Hospital","Auburn","New South Wales","2144","Australia","AU",{"type":128,"coordinates":129},"Point",[130,131],151.03333,-33.85,{"lat":131,"lon":130},[134],{"name":135,"role":113,"phone":114,"phoneExt":66,"email":115},"Nicholas G Burgess, MBChB,FRACP",{"facility":5,"status":66,"city":137,"state":123,"zip":138,"country":125,"countryCode":126,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Westmead","2145",{"type":128,"coordinates":140},[141,142],150.98768,-33.80383,{"lat":142,"lon":141},[145,146],{"name":135,"role":113,"phone":114,"phoneExt":66,"email":115},{"name":117,"role":113,"phone":114,"phoneExt":66,"email":118},{"type":110,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Nicholas Burgess","Professor and Staff Specialist Gastroenterologist","100655559","right-colon-enema-to-improve-bowel-preparation-quality-during-colonoscopy-100655559",false,"NCT07813013","Right Colon Enema to Improve Bowel Preparation Quality During Colonoscopy","RIGHT-CLEAN Trial: A Multi-centre Randomised Controlled Trial of Intra-procedural Right Colon Enema Versus no Enema to Improve Total Colonic Bowel Preparation at Colonoscopy.","RIGHT-CLEAN","Inclusion Criteria:\n\n* Age 18 to 85 years\n* Undergoing elective full colonoscopy for any indication\n* Successful caecal intubation achieved during the procedure, confirmed prior to randomisation\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Emergency colonoscopy\n* Known inflammatory bowel disease with active colitis in the examined segment\n* Familial polyposis syndromes\n* Prior major right hemicolectomy or altered anatomy preventing standard right colon assessment\n* Known obstructing colorectal malignancy precluding safe progression or adequate examination\n* Pregnancy\n* Renal failure (eGFR less than 30 mL\u002Fmin)\n* Previous sodium phosphate enema within the preceding 24 hours\n* Contraindication to sodium phosphate administration as determined by the treating endoscopist",true,"ALL","18 Years","85 Years",{"count":163,"type":164},320,"ESTIMATED","INTERVENTIONAL",[167],"NA","Colonoscopy is a test that lets doctors look inside the large bowel to find and remove growths called polyps, which can develop into bowel cancer. Before the test, people take a bowel preparation to empty the bowel. Even so, the right side of the bowel is often not clean enough, and polyps there can be missed.\n\nThis study is testing whether giving an enema (a small amount of fluid passed into the bowel) during the colonoscopy makes the right side of the bowel cleaner. Participants having a routine colonoscopy at Westmead Hospital or Auburn Hospital will be assigned by chance to either receive the enema during the procedure or to have their colonoscopy in the usual way. Neither group takes any extra preparation at home.\n\nThe researchers will compare how clean the right side of the bowel is in each group, using a standard scoring system, and will also look at how many polyps are found. The aim is to find out whether this simple step improves the quality of colonoscopy.",[170,171,172,173],"Colonic Polyps","Colorectal Neoplasms","Colonoscopy","Bowel Preparation Quality",[175,176,177,178,179,180,181],"Right Colon","Enema","Boston Bowel Preparation Scale","Adenoma Detection Rate","Bowel Preparation","Colonosocpy","Colon Polyps","NOT_YET_RECRUITING","2026-09-20",{"date":185,"type":186},"2026-09-24","ACTUAL",{"date":188,"type":164},"2026-11-01",{"date":190,"type":164},"2028-11-01",{"name":5,"class":6},2]