Non-invasive Assessment of Colonic Motility

NCT04624334 | Terminated

• 1 other identifier: 110933
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Disease; Functional Constipation; Electroenterography; Slow Transit; Hirschsprung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• EEnG questionnaire score

  Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo

• 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

Study Arms (4)

Children with motility disorder

Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire

Healthy children

Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire

Adults with motility disorder

Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire; Other: Gold Standard Questionnaire

Healthy adults

Other: Elektro-Entero-Graphy procedure; Other: EEnG Questionnaire

Interventions

Elektro-Entero-Graphy procedure OTHER

Fasting, after which pre- and postprandial EEnG measurements are performed.

Adults with motility disorder; Children with motility disorder; Healthy adults; Healthy children

EEnG Questionnaire OTHER

Filling out questionnaire about EEnG procedure.

Adults with motility disorder; Children with motility disorder; Healthy adults; Healthy children

Gold Standard Questionnaire OTHER

Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.

Adults with motility disorder; Children with motility disorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Colonic Diseases; Hirschsprung Disease

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Megacolon; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• S.M.B.I. Botden, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 10, 2020
• Study Start: February 25, 2021
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the results.
• Access Criteria: Upon reasonable request via e-mail.

Locations

NL (1)