TerminatedNot Applicable

Non-invasive Assessment of Colonic Motility

Stopped: Money issues

Netherlands34 participantsStarted 2021-02-25

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Power Percent Difference

Timeframe: During EEnG procedure

Trial details

NCT IDNCT04624334

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-12

View on ClinicalTrials.gov More Colon Disease trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.