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Completed

NCT Number: NCT01695915

Diurnal Variation in Rectal Diameter

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

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric department, Kolding Hospital

Kolding, 6000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transabdominal Ultrasound

Procedure

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

Primary outcomes

  1. Rectal diameter

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Line Modin

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 28, 2012
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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