[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dysmotility\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dysmotility":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100653722","comparison-of-a-new-non-invasive-device-with-the-current-invasive-gold-standard-investigation-to-assess-movement-and-function-of-the-large-bowel-in-children-100653722",false,"NCT07789782","Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children","Validation of Body Surface Colonic Mapping, a Non-invasive Tool for Assessing Colonic Motility in Children","Inclusion Criteria:\n\n1. Is aged 18 years or less at enrolment.\n2. Has undergone a repeat rectal biopsy to exclude a retained segment of aganglionic colon (Hischsprung disease (HD) cohort only).\n\nExclusion Criteria:\n\n1. Has undergone primary surgical repair of HD or (anorectal malformation (ARM) within 12 months of the study. Is less than twelve months following primary surgical correction of HD or ARM (HD or ARM cohorts only).\n2. Has a prior diagnosis of:\n\n   i. Intellectual disability or a spinal abnormality, such that continence is unlikely to be attainable; ii. Malignant (cancer) conditions, receiving chemotherapy; iii. GMFCS IV or V.\n3. Is unable to attend for and\u002For engage in consent process or assessments, including due to language restriction.","ALL","6 Months","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if the new non-invasive device (Body Surface Colonic Mapping) works to accurately assess colonic movement and function in children.The main questions it aims to answer are:\n\n* Are Body Surface Colonic Mapping (BSCM) recordings comparable with gold-standard colonic manometry recordings (HRCM - High Resolution Colonic Manometry) in the paediatric population?\n* What are the effects of bowel preparation on colonic function assessed using BSCM?\n\nChildren with clinical recommendation of colonic and\u002For anorectal manometry (clinical tests used to assess colonic function) for investigation of persistent bowel dysfunction symptoms will be invited to participate. We will perform and compare simultaneous recordings of manometry and BSCM in children, in order to demonstrate same colonic function measurements recorded by the two devices in this population. Eligible participants who consent to inclusion in the study will undergo colonoscopy and placement of a large bowel catheter, according to usual Royal Children's Hospital (RCH) practice. These involve administration of oral laxatives for bowel preparation and maintaining a clear fluids diet 24 hours prior to the investigation.\n\nAhead of the simultaneous devices recordings, patients will also be invited to attend the hospital 2-4 weeks prior to have non-invasive BSCM recording only. The aim of this part of the study is to have a BSCM recording in the same patient once with the \"physiological state\" colon (early hospital visit without any bowel preparation administration) and once with the \"non-physiological state\" colon (time of colonoscopy, colonic manometry and BSCM with bowel preparation).",[27,28,29,30,31,32],"Bowel Dysfunction","Dysmotility","Hirschsprung Disease","Anorectal Malformations","Constipation","Functional Constipation (FC)",[34,35,36,37,38,39],"bowel dysmotility","constipation","paediatric","pediatric","Hirschsprung disease","Anorectal malformations","NOT_YET_RECRUITING","2026-08-31",{"date":43,"type":44},"2026-09-02","ACTUAL",{"date":46,"type":21},"2026-09",{"date":48,"type":21},"2031-12",{"name":50,"class":51},"Murdoch Childrens Research Institute","OTHER"]