Diurnal Variation in Rectal Diameter

Constipation Clinical Trial

Official title:

Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695915
• Other study ID #: DV-Rect-UL
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: November 15, 2012
• Start date: September 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

Constipated Inclusion Criteria:

• Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.

Exclusion Criteria:

• Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.

• Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.

Healthy inclusion Criteria:

• Children between 4 and 12 years of age.

Healthy exclusion Criteria:

• Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.

• Children receiving drugs known to affect bowel function during a 2 month period before initiation.

• Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Intervention

Procedure:
• Transabdominal ultrasound
Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.

Locations

Country	Name	City	State
Denmark	Pediatric department, Kolding Hospital	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Line Modin	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rectal diameter		24 hours	No