Electro-Entero-Graphy (EEnG) for non-invasive diagnosis of motility disorders of the bowel
- Conditions
- constipationobstruction10017977
- Registration Number
- NL-OMON51036
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
All subjects: babies/children < 12 years and adults > 18 years.
For patients < 12 years:
o suffering from surgically untreated HSCR as determined by a rectal biopsy, or
o suspected of HSCR, for which a rectal biopsy is planned
o suffering from a surgically untreated colonic motility disorder as
previously diagnosed.
For adult patients:
o Suffering from a (suspected,) surgically untreated functional colonic
motility disorder (such as slow-transit constipation, idiopathic/therapy
resistant constipation), as diagnosed previously or will be diagnosed in the
near future using the gold standard method.
All subjects:
- For adults: BMI > 27 kg/m2
- For babies/children: weight for length > 2.5 standard deviation of WHO Child
Growth Standard
- Pregnancy
- Diabetes
- Any food intolerance
- Intestinal stoma
- Continuous tube feeding
Healthy controls:
- Any known gastro-intestinal disorders
- Use of laxatives in the past two years
Patients:
- (partially) resected small intestines and/or colon
- inflammatory bowel diseases
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the relative power increase (pre-prandial vs.<br /><br>post-prandial) of the EEnG signal (in mV/Hz^2) in the relevance frequency<br /><br>region for colonic motility. This power increase can then be compared between<br /><br>healthy subjects and patients to investigate whether colonic motility can be<br /><br>measured using EEnG and also whether EEnG could be used as diagnostic tool for<br /><br>colonic motility disorders.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The questionnaires are summarized in a grand total score, which can be used to<br /><br>compare the burden of the EEnG procedure with the Gold Standard procedures.</p><br>