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

Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel

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.

Study Overview

• Status: Terminated
• Conditions: Functional Constipation; Hirschsprung Disease; Colon Disease; Slow Transit; Electroenterography
• Intervention / Treatment: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy adults	Other: Elektro-Entero-Graphy procedure; Fasting, after which pre- and postprandial EEnG measurements are performed.; Other: EEnG Questionnaire; Filling out questionnaire about EEnG procedure.
Children with motility disorder	Other: Elektro-Entero-Graphy procedure; Fasting, after which pre- and postprandial EEnG measurements are performed.; Other: EEnG Questionnaire; Filling out questionnaire about EEnG procedure.; Other: Gold Standard Questionnaire; Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
Healthy children	Other: Elektro-Entero-Graphy procedure; Fasting, after which pre- and postprandial EEnG measurements are performed.; Other: EEnG Questionnaire; Filling out questionnaire about EEnG procedure.
Adults with motility disorder	Other: Elektro-Entero-Graphy procedure; Fasting, after which pre- and postprandial EEnG measurements are performed.; Other: EEnG Questionnaire; Filling out questionnaire about EEnG procedure.; Other: Gold Standard Questionnaire; Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: S.M.B.I. Botden, MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): May 12, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Digestive System Abnormalities; Megacolon; Constipation; Hirschsprung Disease; Colonic Diseases
• Other Study ID Numbers: 110933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be available to other researchers on reasonable request.
• IPD Sharing Time Frame: After publication of the results.
• IPD Sharing Access Criteria: Upon reasonable request via e-mail.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No