Diurnal Variation in Rectal Diameter

Completed

• Conditions: Constipation
• Interventions: Procedure: Transabdominal ultrasound

• Registration Number: NCT01695915
• Lead Sponsor: Line Modin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-15
• Last Update Posted: 2012-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Transabdominal ultrasound	Transabdominal ultrasound
Constipated	Transabdominal ultrasound	Transabdominal ultrasound

Primary Outcome Measures

Name	Time	Method
Rectal diameter	24 hours

Trial Locations

Locations (1)

Pediatric department, Kolding Hospital; 🇩🇰 Kolding, Denmark