Clinical trial NCT04624334: Non-invasive Assessment of Colonic Motility
Official title: Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colon Disease
Functional Constipation
Electroenterography
Slow Transit
Hirschsprung Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Power Percent Difference
timeFrame: During EEnG procedure
Secondary outcomes:
measure: EEnG questionnaire score
timeFrame: Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo
measure: Gold Standard questionnaire score
timeFrame: 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
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: S.M.B.I. Botden, MD
role: PRINCIPAL_INVESTIGATOR
References: