Non-invasive Assessment of Colonic Motility

Functional Constipation Clinical Trial

— non-CoMoti  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04624334
• Other study ID #: 110933
• Status: Terminated
• Start date: February 25, 2021
• Est. completion date: May 12, 2022

Study information

• Verified date: April 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases
• Constipation
• Electroenterography
• Functional Constipation
• Hirschsprung Disease
• Slow Transit

Intervention

Other:
• Elektro-Entero-Graphy procedure
Fasting, after which pre- and postprandial EEnG measurements are performed.
• EEnG Questionnaire
Filling out questionnaire about EEnG procedure.
• Gold Standard Questionnaire
Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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