Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
34 participants
OBSERVATIONAL
2021-02-25
2022-05-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Children with motility disorder
Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
Healthy children
Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
Adults with motility disorder
Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
Healthy adults
Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
Interventions
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Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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S.M.B.I. Botden, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Other Identifiers
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110933
Identifier Type: -
Identifier Source: org_study_id
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