Non-invasive Assessment of Colonic Motility

Study Overview
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Brief Summary
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The current diagnostic process of colonic motility disorders often takes a long time and involves multiple invasive, painful and/or unnecessary diagnostic procedures. To improve this diagnostic process, the potential of Electro-Entero-Graphy (EEnG) is investigated. During the EEnG procedure, several surface electrodes are positioned (under ultrasound guidance) on the abdomen so that electrical activity originating in the colon can be measured. Measurements will be performed after a period of fasting (when the colon is 'silent') and just after a meal (when the colon is moving) in both participants suffering from colonic motility disorders and healthy controls. It is hypothesized that these measurements are an indication of colonic motility and can be used as a diagnostic tool for colonic motility disorders. It is also hypothesized that this EEnG procedure is not more burdensome than the Gold Standard procedures for diagnosing colonic motility disorders. This will be assessed using questionnaires.

Official Title
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Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel

Conditions
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Colon Disease, Functional Constipation, Electroenterography, Slow Transit, Hirschsprung Disease

Intervention / Treatment
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* Other: Elektro-Entero-Graphy procedure
* Other: EEnG Questionnaire
* Other: Gold Standard Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants: Age ≤ 11 years for babies and children Age ≥ 18 years for adults. Patients For babies/children: suffering from surgically untreated HSCR as determined by a rectal biopsy, or suspected of HSCR, for which a rectal biopsy is planned For adults: Suffering from a (suspected,) surgically untreated functional colonic motility disorder (such as slow-transit constipation, idiopathic/therapy resistant constipation of the colon), as diagnosed previously or will be diagnosed in the near future using the gold standard method. Exclusion criteria: All participants: For adults: BMI > 27 kg/m2 For babies/children: weight for length > 2.5 standard deviations of WHO Child Growth Standard Pregnancy Diabetes Any food intolerance Presence of an intestinal stoma Use of continuous tube feeding Healthy controls: The presence of any known gastro-intestinal conditions Use of laxatives in the past two years Participants with (suspected) motility disorder: (Part of) colon removed Inflammatory bowel disease
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with motility disorder<br> | Other: Elektro-Entero-Graphy procedure<br>* Fasting, after which pre- and postprandial EEnG measurements are performed.<br>Other: EEnG Questionnaire<br>* Filling out questionnaire about EEnG procedure.<br>Other: Gold Standard Questionnaire<br>* Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.<br>|
| Healthy children<br> | Other: Elektro-Entero-Graphy procedure<br>* Fasting, after which pre- and postprandial EEnG measurements are performed.<br>Other: EEnG Questionnaire<br>* Filling out questionnaire about EEnG procedure.<br>|
| Adults with motility disorder<br> | Other: Elektro-Entero-Graphy procedure<br>* Fasting, after which pre- and postprandial EEnG measurements are performed.<br>Other: EEnG Questionnaire<br>* Filling out questionnaire about EEnG procedure.<br>Other: Gold Standard Questionnaire<br>* Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.<br>|
| Healthy adults<br> | Other: Elektro-Entero-Graphy procedure<br>* Fasting, after which pre- and postprandial EEnG measurements are performed.<br>Other: EEnG Questionnaire<br>* Filling out questionnaire about EEnG procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power Percent Difference | Relative power change when comparing pre-prandial EEnG measurements to post-prandial measurements. Power will be calculated as the mean amplitude (mV^2/Hz) in a bandwidth of 2 cycles per minute around the dominant frequency related to colonic movements (between 2-10 cycles per minute). | During EEnG procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEnG questionnaire score | Burden score of EEnG procedure as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all. | Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo | 
| Gold Standard questionnaire score | Total burden score of Gold Standard procedure used to diagnose motility disorder as assessed by a self created questionnaire (in collaboration with medical doctors, a psychologist and representatives of the patients association). A mean score of 0 indicates maximum burden, a mean score of 10 means no burden at all. | Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo, or directly after the gold standard procedure, which some subjects will undergo in the near future at time of inclusion |