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

Summary

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).

Conditions

• Bowel Dysfunction
• Dysmotility
• Hirschsprung Disease
• Anorectal Malformations
• Constipation
• Functional Constipation (FC)

Interventions

DEVICE

Body Surface Colonic Mapping

BSCM 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).

Sponsors & Collaborators

• Royal Children's Hospital

  collaborator OTHER

• Flinders University

  collaborator OTHER

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Sebastian K King, MBBS, PhD, FRACS · Royal Children's Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2031-12-31

Completion

2031-12-31

Countries

• Australia

Study Locations