Non-invasive Assessment of Colonic Motility (non-CoMoti)

Radboud University Medical Center

Status

Terminated

Conditions

Hirschsprung Disease

Functional Constipation

Electroenterography

Colon Disease

Slow Transit

Treatments

Other: EEnG Questionnaire

Other: Elektro-Entero-Graphy procedure

Other: Gold Standard Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04624334

110933

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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