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:
* Are Body Surface Colonic Mapping (BSCM) recordings comparable with gold-standard colonic manometry recordings (HRCM - High Resolution Colonic Manometry) in the paediatric population? * What are the effects of bowel preparation on colonic function assessed using BSCM?
Children with clinical recommendation of colonic and/or 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.
Ahead 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).
Is aged 18 years or less at enrolment.
Has undergone a repeat rectal biopsy to exclude a retained segment of aganglionic colon (Hischsprung disease (HD) cohort only).
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).
Is unable to attend for and/or engage in consent process or assessments, including due to language restriction.
Single group
Body Surface Colonic Mapping
DeviceBSCM includes a sticky grid pad device connected to a reader that detects bowel motility. The sticky gid pad is the single-use disposable part of BSCM, so after use in each participant, the pads are disposed of. The grid pads are made of 64 electrodes and can be cut along pre-designed marks to allow for appropriate fitting on the child's abdomen. The sticky grid will be appropriately sized and applied to the patients' abdomen in the operating theatre recovery room after colonoscopy and correct positioning in relation to the manometry catheter will be ensured with an abdominal X-Ray (AXR). The device will be on the patients' abdomen until for the whole duration of the investigation (about 6 hours).
Outcome measure 1: Motility Index (MI) as measured by Body Surface Colonic Mapping (BSCM) (to be compared with the Motility Index of the alternative method [colonic manometry])
BSCM measures the electrical activity underlying colonic contractions. Data captured via BSCM can be characterised as a MI. This will be compared with that for the alternative method recordings (colonic manometry).
Outcome measure 2: Motility Index (MI) as measured by colonic manometry (to be compared with the Motility Index of the alternative method [Body Surface Colonic Mapping])
Colonic manometry measures the contact force of contractile activity within the gut, recorded as a series of pressure waves. These fluctuations in the pressure profile are quantified using a MI.
Change in Motility Index as measured by BSCM on the day of the main investigation (BSCM and HRCM via colonoscopy) versus a stand-alone BSCM-only assessment performed 2-4 weeks beforehand.
The effects of bowel preparation upon colonic motor patterns (MI) will be studied by comparing the BSCM in children having undergone bowel preparation prior to the BSCM and HRCM \["prepared colon"\] with the MI in children who have not received bowel preparation at the standalone BSCM \[unprepared "physiological state" colon\]. Bowel preparation includes laxatives, a clear fluid diet for 24 hours, an anaesthetic and gas inflation at colonoscopy.
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Murdoch Childrens Research Institute
Lead sponsor
Royal Children's Hospital
Collaborator
Flinders University
Collaborator
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