Diurnal Variation in Rectal Diameter

NCT01695915 | Completed

• 1 other identifier: DV-Rect-UL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Keywords

constipation; children; healthy; rectal diameter

Outcome Measures

Primary Outcomes (1)

• Rectal diameter

  24 hours

Study Arms (2)

Healthy

Transabdominal ultrasound

Procedure: Transabdominal ultrasound

Constipated

Transabdominal ultrasound

Procedure: Transabdominal ultrasound

Interventions

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.

Constipated; Healthy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• 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 between 4 and 12 years of age.
• 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.

Sponsors & Collaborators

• Line Modin: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Pediatric department, Kolding Hospital

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Line Modin, MD

  Kolding Sygehus

  PRINCIPAL INVESTIGATOR

• Marianne Jakobsen, MD, phd

  Kolding Sygehus

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

DK (1)