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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with motility disorder |
| ||
| Healthy children |
| ||
| Adults with motility disorder |
| ||
| Healthy adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elektro-Entero-Graphy procedure | Other | Fasting, after which pre- and postprandial EEnG measurements are performed. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients
For babies/children:
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:
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All subjects fulfilling the in- and exclusion criteria will be included. Participants with (suspected) motility disorder will be recruited mainly in the Radboudumc and with the help from the Hirschsprung's patient association.
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| Name | Affiliation | Role |
|---|---|---|
| S.M.B.I. Botden, MD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525 GA | Netherlands |
IPD will be available to other researchers on reasonable request.
After publication of the results.
Upon reasonable request via e-mail.
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D006627 | Hirschsprung Disease |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
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| EEnG Questionnaire | Other | Filling out questionnaire about EEnG procedure. |
|
| Gold Standard Questionnaire | Other | Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder. |
|
| 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 |
| D008531 | Megacolon |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |