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Diurnal Variation in Rectal Diameter

NCT ID: NCT01695915

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Constipation

Keywords

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constipation children healthy rectal diameter

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy

Transabdominal ultrasound

Transabdominal ultrasound

Intervention Type PROCEDURE

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

Transabdominal ultrasound

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* Children between 4 and 12 years of age.

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.


* 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Line Modin

OTHER

Sponsor Role lead

Responsible Party

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Line Modin

Medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Line Modin, MD

Role: PRINCIPAL_INVESTIGATOR

Kolding Sygehus

Marianne Jakobsen, MD, phd

Role: STUDY_DIRECTOR

Kolding Sygehus

Locations

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Pediatric department, Kolding Hospital

Kolding, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DV-Rect-UL

Identifier Type: -

Identifier Source: org_study_id