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CompletedNCT01695915Updated Nov 16, 2012

Diurnal Variation in Rectal Diameter

An observational study in Constipation, sponsored by Line Modin. Completed at 1 site in Denmark. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-16.

Sponsored by Line Modin · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
4 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Constipation

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Keywords

  • constipation
  • children
  • healthy
  • rectal diameter
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 129 observational studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Line Modin is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
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.

Eligibility 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • Healthy

    Transabdominal ultrasound

    Procedure: Transabdominal ultrasound

  • Constipated

    Transabdominal ultrasound

    Procedure: Transabdominal ultrasound

Interventions

  • ProcedureTransabdominal ultrasound

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

06

What researchers measure

Primary outcomes

  1. Rectal diameter

    Time frame: 24 hours

07

Study locations

1 site
  • Pediatric department, Kolding Hospital
    Kolding, 6000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01695915
Lead sponsor
Line Modin
Collaborators
University of Southern Denmark
Responsible party
Line Modin (Medical doctor, Vejle Hospital) — Sponsor-investigator
First posted
Sep 28, 2012
Start date
Sep 2012
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Nov 16, 2012

Study contacts

Line Modin, MD
principal investigator · Kolding Sygehus
Marianne Jakobsen, MD, phd
study director · Kolding Sygehus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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