Electro-Entero-Graphy (EEnG) for non-invasive diagnosis of motility disorders of the bowel

Bowel problems are encountered in a large part of the population, ranging from
babies and children to adults. To treat these patients adequately, it is
important that the right diagnose is made. This, however, is easier said than
done, especially for motility disorders. These disorders are often
misunderstood, and the process to diagnosis is often long and is filled with
diagnostics that are burdensome, painful and/or sometimes even unnecessary. To
improve this process, we aim to investigate if Electro-Entero-Graphy (EEnG),
where surface electrodes are positioned on the abdomen to measure electrical
activity originating in the colon, could be used as a new, non-invasive
diagnostic tool in the diagnosis of patients suffering from colonic motility
disorders.

The primary objectives of this study are:
- Can EEnG measure colonic motility/activity?
- Can EEnG be used to distinguish between healthy subjects and patients
suffering from a colonic motility disorder.

Secundary objective:
- What is the reproducibility of the EEnG measurements in healthy adults?
- How is the patient experienced burden of the EEnG procedure relative to the
patient experienced burden of the Gold Standard diagnostic method by which the
colonic motility disorders have been diagnosed.

This study is an intervention study in which the measurement outcomes of
healthy controls are compared to those of patients.

All participants are asked to fast at least 4 hours (3 hours for babies < 1
years old) before the start of the EEnG procedure.
At the start of the EEnG procedure, the electrodes are positioned on the
abdomen (under ultrasound guidance) and the participants are asked to lay still
for 20 minutes.
Next, they have to eat a standardized meal (in advance composed together with
them), after which they have to lay still for another 20 minutes.
At the end, they are asked to complete a questionnaire regarding the burden
they experienced from the procedure.
Patients who are already diagnosed with a colonic motility disorder are also
asked to fill out a questionnaire regarding the burden of the Gold Standard
diagnostic they are diagnosed with.
Patients getting the Gold Standard diagnostic method in the near future will
fill out this questionnaire afterwards.

The burden will mainly consist of the duration of the procedure (around 1.5
hours for children and patients, around 3 hours in total for healthy adults)
and can be a little boring (laying still for 20 minutes for two times). There
are no risks associated with participation: the used devices (ultrasound and
electrodes + amplifier) are approved for medical use and do not pose any risk.

The importance of examining EEnG als diagnostic tool in babies and children in
this study is fourfold:
- motility disorders comprise 3-5% of the consultations of paediatricians;
- the current diagnostic process often involves anesthesia, which negatively
influences brain development in young children;
- the current uncertain waiting time and invasive diagnostics pose a great
burden to the parents;
- only babies and children can present with untreated Hirschsprung*s disease,
which is the ultimate colonic motility disorder to evaluate the potential of
EEnG to diagnose colonic motility disorders. In Hirschsprung's disease, the
nerves controlling colonic motility are absent in (a part of) the colon, which
means that if EEnG could be used as diagnostic tool, this should be the case in
patients suffering from Hirschsprung's disease.