Diurnal Variation in Rectal Diameter

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

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

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Procedure: Transabdominal ultrasound

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Pediatric department, Kolding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Constipated children are recruited from the outpatient clinic at Kolding pediatric department. A list of patients which have been given the diagnose constipation are drawn from the computer and reviewed. Children between 4-12 years who fulfill the Rome III criteria of constipation and have been taking PEG maintenance treatment at least 1 month, are contacted by telephone for possible participation in the study.

Healthy participants without constipation or other diseases affecting the gastrointestinal tract were recruited among the employees of the Department of Pediatrics at Kolding Hospital.

Written informed consent was obtained from both parents before any procedures were initiated.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Transabdominal ultrasound	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.
Constipated; Transabdominal ultrasound	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rectal diameter	24 hours

Collaborators and Investigators

• Sponsor: Line Modin
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Line Modin, MD, Kolding Sygehus; Study Director: Marianne Jakobsen, MD, phd, Kolding Sygehus

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 16, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: children; healthy; constipation; rectal diameter
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: DV-Rect-UL