Non-invasive Assessment of Colonic Motility

Terminated

• Conditions: Colon Disease; Functional Constipation; Slow Transit; Electroenterography; Hirschsprung Disease
• Interventions: Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire

• Registration Number: NCT04624334
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Study Start: 2021-02-25
• Status Verified: 2022-04
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with motility disorder	Gold Standard Questionnaire	-
Adults with motility disorder	Elektro-Entero-Graphy procedure	-
Children with motility disorder	Elektro-Entero-Graphy procedure	-
Children with motility disorder	EEnG Questionnaire	-
Children with motility disorder	Gold Standard Questionnaire	-
Healthy children	Elektro-Entero-Graphy procedure	-
Adults with motility disorder	EEnG Questionnaire	-
Healthy adults	Elektro-Entero-Graphy procedure	-
Healthy adults	EEnG Questionnaire	-
Healthy children	EEnG Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Power Percent Difference	During EEnG procedure	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).

Secondary Outcome Measures

Name	Time	Method
EEnG questionnaire score	Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo	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.
Gold Standard questionnaire score	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	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.

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands