Diurnal Variation in Rectal Diameter

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Line Modin, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01695915
First received: September 27, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Constipation
Procedure: Transabdominal ultrasound

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Rectal diameter [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695915

Locations
Denmark
Pediatric department, Kolding Hospital
Kolding, Denmark, 6000
Sponsors and Collaborators
Line Modin
University of Southern Denmark
Investigators
Principal Investigator: Line Modin, MD Kolding Sygehus
Study Director: Marianne Jakobsen, MD, phd Kolding Sygehus
  More Information

No publications provided

Responsible Party: Line Modin, Medical doctor, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01695915     History of Changes
Other Study ID Numbers: DV-Rect-UL
Study First Received: September 27, 2012
Last Updated: November 15, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
constipation
children
healthy
rectal diameter

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014