Validation of Body Surface Colonic Mapping, a Non-invasive Tool for Assessing Colonic Motility in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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])
研究概览
简要总结
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).
详细描述
Potential participants will be identified by RCH surgeon, Prof. Sebastian King (Paediatric Colorectal Surgeon). Patients will be identified following outpatient review or referral to RCH (Department of Paediatric Surgery), when colonic motility assessment is recommended for investigation of bowel dysfunction. All patients will be reviewed in clinic by an independent paediatric gastroenterologist (Dr Mark Safe), who has undergone post-fellowship training in the assessment of paediatric gastrointestinal motility.
All patients planned to undergo colonic motility assessment will be screened for study eligibility. Screening for eligibility will be undertaken by study investigators the electronic medical record (EPIC).
Once identified, patients will be reviewed in the monthly motility clinic with Prof. King and Dr Safe, which is part of the standard of care at RCH prior to colonic manometry. At that time, after completion of the clinical review, families and patients will be given verbal information about the opportunity to take part to the research study while undergoing colonic manometry. Further information about the study (Recruitment letter and Participant information) will be emailed to them after the consultation. This will follow-up with a phone call to the family by Dr Comella after a week to establish if the family and patient are interested in taking part to the research study. If consenting, this will be documented and the relevant hospital admissions organised. Written consent will be obtained on the day of the first in-person appointment. It will be explicit in the initial and all subsequent contact that there is no imperative for the child to participate; patient care will not be compromised by electing not to participate in the project.
Participants will be able to stop the study at any time they would like if they do not want to complete it. They will be undertaking colonic manometry as part of their clinical indication by their physician, who will run the test to gain information for their clinical management. The BSCM data will be part of the research project, which aims to compare these data to the current colonic motility assessment gold-standard that is colonic manometry. The family or patient can stop the research side of the study at any stage.
Participants will not receive incentives or compensation for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
- •Has a prior diagnosis of:
- •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.
- •Is unable to attend for and/or engage in consent process or assessments, including due to language restriction.
研究组 & 干预措施
Paediatric patients with bowel dysmotility
Paediatric patients with bowel dysmotility and indications for colonic manometry investigation will have Body Surface Colonic Mapping applied to their abdomen for comparison with colonic manometry recordings.
干预措施: Body Surface Colonic Mapping (Device)
结局指标
主要结局
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])
时间窗: On the day of the main investigation, from the beginning of colonic manometry and BSCM assessments until the end of the tests, with an estimated testing time of 6 hours.
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])
时间窗: On the day of the main investigation, from the beginning of colonic manometry and BSCM assessments until the end of the tests, with an estimated testing time of 6 hours.
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.
次要结局
- 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.(Standalone visit for BSCM recording (duration about 2 hours). Main visit for the BSCM and HRCM via colonoscopy (duration about 6 hours).)